LCPPV Required
No

Comments
There is no legal requirement to appoint an LCPPV in Austria, however the Austrian competent
authority (AGES) can require the nomination of LCPPV from the MAH. The EMA document says that
“this has not been executed so far since most MAHs nominate contact persons on national level
anyway”.
This is highly unlikely to be requested and most sensible thing to do is not to appoint an LCPPV.

Legislation and Guidelines
The local law § 75i (6) AMG states:
§ 75i. (6) Unbeschadet des Abs. 5 kann das Bundesamt für Sicherheit im Gesundheitswesen die
Benennung einer Kontaktperson für Pharmakovigilanzfragen in Österreich verlangen, die dem
Pharmakovigilanzverantwortlichen Bericht erstattet.

Translation:
Without prejudice to Paragraph 5, the Federal Office for Safety in Health Care can request the
designation of a contact person for pharmacovigilance issues in Austria who will report to the
pharmacovigilance officer.

Registration:
Not applicable

LCPPV Required
Yes

Comments
Nomination of LCPPV is legally required in Belgium. The EMA document states that the requirement
is based on article 66§2 of the Royal Decree 14/12/2066, however the correct legal reference is
article 66§2 of the Royal Decree 14/12/2006 (published on 14th of December 2006) and amended on
10th of June 2013.

Legislation and Guidelines
According to article 12sexies §2 of the Law of 25 March 1964 concerning the medicinal products:
Dans le cadre de ce système de pharmacovigilance, il prend notamment les mesures suivantes :
a) il a de façon permanente et continue à sa disposition une personne possédant les qualifications
appropriées qui est responsable pour la pharmacovigilance, ainsi que, le cas échéant, une personne
de contact en matière de pharmacovigilance au niveau belge qui est rattachée à cette personne
qualifiée, et ce pour chaque dossier permanent du système de pharmacovigilance; le Roi fixe les
conditions auxquelles la personne qualifiée et la personne de contact doivent répondre pour exercer
leurs activités;

Translation:
As part of this pharmacovigilance system, it takes the following measures in particular:
(a) he has permanently and continuously at his disposal a person with the appropriate qualifications
who is responsible for pharmacovigilance, as well as, if applicable, a contact person for
pharmacovigilance at the Belgian level which is attached to this qualified person, and this for each
file permanent pharmacovigilance system; the King sets the conditions under which the qualified
person and the contact person must meet to carry out their activities.
The information about LCPPV requirements is described on the national competent authority
FAMHP website. The information is based on Circular 600, annex I, annex II and QA document that
give more regarding the LCPPV and the nomination process.
According to the circular, the local contact person should meet the following requirements:
• must be contactable 24 hours a day, 7 days a week
• must carry out activities in pharmacovigilance in Belgium
• must have adequate qualifications to carry out his/her activities in pharmacovigilance,
particularly the necessary language skills to talk to partners in the national language of their
choice and to communicate with the qualified person responsible for pharmacovigilance.

Registration
The format for the nomination letter to FAMHP is provided in the Circular 600, in annex I and annex
II, which constitute the notification letter form.
According to the Circular 600, the form can be submitted as PDF to phvinsp@fagg-afmps.be and it
needs to be signed by a representative of the MAH.

LCPPV Required
Yes

Comments
LCPPV is required, unless the EU QPPV is located in Bulgaria.
Legislation and Guidelines
The LCPPV requirement is described in the law for medicinal products in human medicine, Article
191.
Art. 191. (amend. – SG, 102/2012, in force from 21.12.2012)
• The marketing authorisation holder shall select a qualified person with an appropriate
qualification, responsible for vigilance of the medicinal safety.
• The person under Para. 1 shall be established on the territory of a Member State and shall
be permanently at disposal of the marketing authorisation holder.
• In order to assist the activity of the qualified person, the marketing authorisation holder
shall select a person, established on the territory of the Republic of Bulgaria. The
appointment of such a person shall not liberate the qualified person under Para. 1 from
his/her responsibilities under this Chapter

Registration
An LCPPV nomination letter should be sent via email to BDA or delivered as a paper copy in order to
receive a confirmation number

LCPPV Required
Yes

Comments
MAH has to appoint an LCPPV residing in Croatia. HALMED’s requirements are some of the strictest
in Europe.

Legislation and Guidelines
Ordinance on Pharmacovigilance (Official Gazette 83/13) p.7
“proof that the future authorisation holder has a person approved by the Agency for
pharmacovigilance with residence in the Republic of Croatia, or proof of a submitted request to the
Agency for authorisation of a person responsible for pharmacovigilance with residence in the
Republic of Croatia”
Ordinance on Pharmacovigilance (Official Gazette 83/13) Article 32
The authorisation holder is obliged without delay to submit to the Agency the request for the
approval of a change in the person responsible for pharmacovigilance seated in the Republic of
Croatia, pursuant to Articles 26 and 27 of this Ordinance.
Medicinal Product Act (official gazette no. 76/13) Article 3 Point 58
Person of the marketing authorisation holder qualified for pharmacovigilance in the Republic of
Croatia shall mean a doctor of medical science specialised in clinical pharmacology, or a doctor of
medical science, or a doctor of dental medicine, or a graduate pharmacist, or a master of medical
biochemistry, or a doctor of veterinary medicine with two years of experience in pharmacovigilance or two years of experience in his/her profession with appropriately documented training in
pharmacovigilance

Registration
Detailed list of national requirements:

Proof that the future MAH has responsible person for Pharmacovigilance seated in Croatia
authorised by the Agency or proof that application for their approval has been submitted to
HALMED. This submission should be separate from the submission for marketing authorisation.

Documents to be submitted in electronic form:

• Proof of the legal entity’s seat, if the future marketing authorisation holder is a natural or
legal person than the applicant, proof that the seat of the future marketing authorisation
holder is in the EU, valid no longer than six months from the submission date
• Written statement of the marketing authorisation holder not having seat in the Republic of
Croatia about the appointment of a local representative with the seat in the Republic of
Croatia with his contacts

Request for approval of LCPPV should contain:

• original statement of the qualified person of the MAH for appointing local QPPV
• signed CV of the local qualified person
• copy of diploma proving completed education, copy of specialist training completion
certificate (clinical pharmacology), or if the QPPV isn’t a clinical pharmacology specialist
proof of two-year work experience in Pharmacovigilance, i.e. proof that the person has
undergone Pharmacovigilance terms, spontaneous and solicited adverse reactions reporting,
adverse reaction reporting procedure, adverse reaction report grading, Individual Case
Safety Report (ICSR-a), Periodic Safety Update Report (PSUR), Risk Management Plan (RMP)
and Development Safety Update Report (DSUR) training
• proof of residence of the QPPV
• 24-hour contact information on QPPV
• proof of employment of the QPPV at the MAH or a contracted legal person that has a
registered activity for adverse reaction tracking, i.e. Pharmacovigilance activities in the
Republic of Croatia, with whom the MAH has concluded an agreement on Pharmacovigilance
• copy of the agreement on appointing contractual local QPPV
• EV code/codes (PSMF Location EV Code)

If the local QPPV is an employee of the MAH belonging to the same authorization holder group as
the holder submitting the request, instead of copy of the agreement appointing contractual local
QPPV/deputy, a statement signed by QPPV of the MAH stating that the company in which the local
QPPV/deputy is employed is part of the same MAH group will be accepted.

If MAH has authorized a third legal party to conclude agreements for Pharmacovigilance with a legal
entity that has a registered activity for adverse reaction tracking, i.e. Pharmacovigilance activities in
the Republic of Croatia, instead of a copy of the agreement of appointing contractual local
QPPV/deputy, a copy of the authorization given to the third legal entity as well as a copy of the
contract that the third legal entity concluded on behalf the MAH with the contractual legal entity for
Pharmacovigilance in which local QPPV/deputy is employed. MAH appoints one local qualified person for each Pharmacovigilance system regarding medicinal
products that have marketing authorization in the Republic of Croatia.

MAH can submit a request for approval of additional local QPPV, aside from the already appointed
one by HALMED, only if the request addresses a new pharmacovigilance system of the MAH. In the
request for local QPPV approval and deputy of local QPPV, as well as in all the submitted documents
containing signatures, by each signature should be printed name, last name and function of the
signatory.

Information on the approval procedure of local qualified person / deputy responsible for
pharmacovigilance: lqppv@halmed.hr

LCPPV Required
Yes

Comments
For the LCPPV in Cyprus requirement, the EMA document states “Yes” and the comment says “The
pharmaceutical services request the appointment of a local responsible person for
pharmacovigilance residing in Cyprus. The requirements for the local RPPV in CY: healthcare
professionals, biologists or chemists adequately trained.”

Legislation and Guidelines
The Drugs for Human Use (Quality Control, Supply and Prices) Law of 2001 (70 (I) / 2001) states:
(3)(α) Το ειδικευμένο άτομο που αναφέρεται στην παράγραφο (α) του εδαφίου (2) διαμένει και
δραστηριοποιείται στην Ευρωπαϊκή Ένωση και είναι υπεύθυνο για τη δημιουργία και τη διαχείριση
του συστήματος φαρμακοεπαγρύπνησης.
(β) Ο κάτοχος της άδειας κυκλοφορίας υποβάλλει το ονοματεπώνυμο και τα στοιχεία επικοινωνίας
του ειδικευμένου ατόμου στην αρμόδια αρχή και στον Ευρωπαϊκό Οργανισμό Φαρμάκων.
(4) Με την επιφύλαξη των διατάξεων του εδαφίου (3), το Συμβούλιο Φαρμάκων μπορεί να ζητήσει
το διορισμό αρμοδίου επικοινωνίας για θέματα φαρμακοεπαγρύπνησης ο οποίος θα αναφέρεται
στο ειδικευμένο άτομο υπεύθυνο για δραστηριότητες φαρμακοεπαγρύπνησης.

Translation:
(3) (a) The qualified person referred to in paragraph (a) of subsection (2) resides and operates in the
European Union and is responsible for the establishment and management of the pharmacovigilance
system.
(b) The marketing authorization holder shall submit the name and contact details of the qualified
person to the competent authority and to the European Medicines Agency.(4) Without prejudice to the provisions of subsection (3), the Medicines Board may request the
appointment of a pharmacovigilance liaison officer to report to the qualified person responsible for
pharmacovigilance activities.
The Cypriot Ministry of Health has published a circular on requirements for local contact persons.
Unfortunately, the older circulars are no longer available on the website of the pharmaceutical
services of the ministry of health.

The circular states:

Θέμα: Απαιτήσεις για το Τοπικά Ειδικευμένο Άτομο για Φαρμακοεπαγρύπνηση (Local QPPV) /
Υπεύθυνο Άτομο για Φαρμακοεπαγρύπνηση (Local RPPV) – Υπενθύμιση και διευκρινίσεις
Σε συνέχεια της εγκυκλίου των Φαρμακευτικών Υπηρεσιών ημερομηνίας 1 Σεπτεμβρίου 2008, το
Συμβούλιο Φαρμάκων ενημερώνει τους ΚΑΚ για τις τοπικές απαιτήσεις σχετικά με το τοπικά
Ειδικευμένο Άτομο για Φαρμακοεπαγρύπνηση (QPPV) και το τοπικά Υπεύθυνο Άτομο για
Φαρμακοεπαγρύπνηση (RPPV). Υπενθυμίζονται οι ΚΑΚ για την υποχρέωση1 διορισμού ενός τοπικά
QPPV/RPPV για την Κυπριακή αγορά εάν ο EU/EEA QPPV δεν διαμένει και δεν δραστηριοποιείται
στην Κυπριακή Δημοκρατία. Σύμφωνα με το Συμβούλιο Φαρμάκων, ο τοπικά QPPV/RPPV, ο οποίος
θα διαμένει στην Κύπρο, πρέπει να είναι επαγγελματίας υγείας, βιολόγος ή χημικός κατάλληλα
εκπαιδευμένος στη φαρμακοεπαγρύπνηση. Πρέπει, επίσης, να κατέχει άπταιστα την ελληνική
γλώσσα προκειμένου να εκτελέσει αποτελεσματικά τις δραστηριότητες της φαρμακοεπαγρύπνησης
που έχουν ανατεθεί σε αυτόν / αυτήν από το EU/EEA QPPV του ΚΑΚ. Όσοι ΚΑΚ δεν έχουν ακόμη
ορίσει ένα κατάλληλο τοπικά υπεύθυνο άτομο για τη φαρμακοεπαγρύπνηση, θα πρέπει να το
πράξουν άμεσα και να ενημερώσουν το Συμβούλιο Φαρμάκων ως προς τα στοιχεία του προσώπου
αυτού χρησιμοποιώντας το συνημμένο έντυπο κοινοποίησης. Οι ΚΑΚ που δεν έχουν κοινοποιήσει
στο Συμβούλιο Φάρμακων τα απαιτούμενα στοιχειά του νυν τοπικού υπεύθυνου ατόμου για την
φαρμακοεπαγρύπνηση πρέπει επίσης να ενημερώσουν το Συμβούλιο Φαρμάκων με τα
επικαιροποιημένα στοιχεία χρησιμοποιώντας επίσης το συνημμένο έντυπο. Θα πρέπει να
σημειωθεί ότι δημόσιοι υπάλληλοι ή άτομα τα οποία δεν μπορούν να είναι διαθέσιμοι συνεχώς δεν
είναι εφικτό να οριστούν ως τοπικοί QPPV/RPPV. Είναι όμως επιτρεπτό για τον τοπικά QPPV/RPPV
να διοριστεί σαν τοπικά QPPV/RPPV σε πέραν του ενός ΚΑΚ. Για οποιαδήποτε διευκρίνιση
παρακαλείσθε όπως επικοινωνείτε με τη Μονάδα Φαρμακοεπαγρύπνησης των Φαρμακευτικών
Υπηρεσιών.

The English part of the circular states:

Re: Requirements for local QPPV/RPPV – Reminder and Clarification
Further to the Circular of September 1 2008 concerning the QPPV and local contact persons, the
Drugs Council wishes to remind Marketing Authorisation Holders of the requirement 2 to nominate
a local Qualified/Responsible Person for Pharmacovigilance for the Cyprus market, should the EU
QPPV not reside and operate in the Republic of Cyprus.
The Drugs Council requires this local QPPV/RPPV, who will reside in Cyprus, to be a qualified
healthcare professional or a biologist or chemist and to have been adequately trained in
pharmacovigilance. Additionally, they must be fluent in written and spoken Greek, in order to
effectively perform the pharmacovigilance activities delegated to him/her by the EU QPPV of the
MAH. Any MAHs who have not yet nominated a suitable person, must do so immediately and will notify
the Drugs Council as to the particulars of the nominated person using the attached notification form.
Other MAHs who may not have notified the change of their local QPPV/RPPV must also notify the
Drugs Council of the updated details using the attached form.
It must be noted that a person currently employed in the public service, or a person who is unable to
be available continuously, may not be nominated as local QPPV/RPPV. It is possible, however, for a
local QPPV/RPPV to be appointed as QPPV/RPPV for more than one MAH.
Please do not hesitate to contact the pharmacovigilance department of the Pharmaceutical Services
should you require any clarification.
2 Article 57 of The Medicines for Human Use (Control of Quality, Supply and Prices) Act of 2001
(70(I) / 2001) and Article 104 of the Directive 2001/83/EC of the European Parliament and of the
Council of 6 November 2001 on the Community code relating to medicinal products for human use,
as amended.

Registration
The above-mentioned circular contains notification form in Greek and in English.

The form can be submitted by email to phscentral@phs.moh.gov.cy.

The form contains the following information:

Name of the nominee (SURNAME, First name):

Contact Details
Address:
24 hour Telephone Number:
Office Telephone Number:
Fax Number:
Email address:

Back-up Arrangements:
Name of Contact (deputy) should the above nominee not be available:
Contact Details:

Checklist of Enclosed/Attached Documents:
• Curriculum vitae Evidence of adequate
• Training and Experience in Pharmacovigilance
• Summary of Responsibilities as outlined in the Pharmacovigilance Agreement/Contract
between the local QPPV/RPPV and the EU/EEA QPPV
• List of Products for which the Local QPPV/RPPV is responsible
• Evidence/declaration of adequate knowledge of Modern Greek
• Other

I, the undersigned, declare that the above information and supporting documents are accurate and
correct to the best of my knowledge. I will be continuously available to receive and respond to queries, reports and any other safety related data from the general public, health care professionals
and the National Authorities. I undertake to maintain a pharmacovigilance training portfolio that will
be made available to the Pharmaceutical Services of the Ministry of Health for review as and when
requested.

Signature:
Date:
Print name:

Additional details regarding the enclosed documents
• The address must be within the Republic of Cyprus
• General enquiry mailboxes (e.g. info@MAH.com) will not be accepted
• Training and Experience in Pharmacovigilance should be analogous to the delegated
responsibilities

LCPPV Required
Yes

Comments
In practice, the national competent authority requests all marketing authorization holders to appoint
an LCPPV, unless the EU QPPV speaks Czech or Slovak.

The LCPPV in the Czech Republic must:
• be able to communicate in Czech or Slovak
• be contactable on a telephone number with the Czech area code
• be established in the territory of the EU

It is acceptable, and practical, to use the same LCPPV for both The Czech Republic as well as Slovakia.

Legislation and Guidelines
The NCA instructs that according to the act on pharmaceuticals, section 91a (3):

Kvalifikovaná osoba odpovědná za farmakovigilanci (§91a)
• Držitel rozhodnutí o registraci musí mít trvale a nepřetržitě k dispozici kvalifikovanou osobu
odpovědnou za farmakovigilanci.
• Kvalifikovaná osoba odpovědná za farmakovigilanci odpovídá za vytvoření a správu
farmakovigilančního systému a musí mít bydliště a plnit své úkoly v oblasti farmakovigilance
na území Evropské unie. Držitel rozhodnutí o registraci sdělí jméno, příjmení a kontaktní
údaje kvalifikované osoby odpovědné za farmakovigilanci Ústavu a agentuře.
• Ústav může požádat držitele rozhodnutí o registraci o jmenování kontaktní osoby pro otázky
farmakovigilance v České republice, která bude podřízena kvalifikované osobě odpovědné za
farmakovigilanci (upřesnění zde).
• Držitel rozhodnutí o registraci je povinen neprodleně informovat Ústav v případě změny
kvalifikované osoby odpovědné za farmakovigilanci nebo změny jejích kontaktních údajů;
obdobně informuje o změnách týkajících se kontaktní osoby.

Translation:
Qualified person responsible for pharmacovigilance (§91a)
• The MAH must keep the qualified person responsible for pharmacovigilance available at all
times.
• The qualified person responsible for pharmacovigilance is responsible for the establishment
and administration of the pharmacovigilance system and must be resident and perform his
pharmacovigilance tasks in the European Union. The marketing authorization holder shall
communicate the name, surname and contact details of the qualified person responsible for
pharmacovigilance to the Institute and the Agency.
• The Institute may request the marketing authorization holder to appoint a contact person for
pharmacovigilance issues in the Czech Republic, who will report to a qualified person
responsible for pharmacovigilance (details here).
• The marketing authorization holder is obliged to immediately inform the Institute in the
event of a change in the qualified person responsible for pharmacovigilance or a change in
his contact details; similarly informs about changes concerning the contact person.

Guideline PHV-6 SÚKL requirements for reporting changes in the PSMF, for appointing the qualified person for pharmacovigilance and for appointing the contact person for pharmacovigilance issues in the Czech Republic

SÚKL has requested the nomination of the contact person by all MAHs who have legal PV obligations in the country:https://www.sukl.cz/leciva/phv-6-verze-3

The QPPV and the contact person for pharmacovigilance issues may be the same person. The contact
person for pharmacovigilance issues is a part of the marketing authorization holder’s pharmacovigilance
system, whose responsibilities are set out and listed in the PSMF. The minimum responsibility of the contact
person for pharmacovigilance issues is to provide the contact between SÚKL and the QPPV.

The contact information in the body of the e-mail must include the e-mail address and telephone number of the contact person for pharmacovigilance issues and the name of the represented marketing authorization holder (all represented marketing authorization holders). The marketing authorization holder may also inform SÚKL of the contact person’s deputy if one is appointed

Registration
The marketing authorization holder is obliged to immediately inform the Institute in the event of a
change in the qualified person responsible for pharmacovigilance or a change in his contact
details; similarly informs about changes concerning the contact person.

If the marketing authorization holder meets the requirements set out above for the appointment of
a contact person for pharmacovigilance issues in the Czech Republic, informs the pharmacovigilance
department electronically by email to the address pharmacovigilance@sukl.cz.

LCPPV Required
No (not in practice)

Comments
The Danish law allows the Danish national competent authority to request an LCPPV appointment
but the authority does not enforce it.

The EMA document states that DKMA has up until now not required of any MAH the appointment of
LCPPV in Denmark.

Legislation and Guidelines
According to Medicines Act § 53, the Danish Health and Medicines Authority may require the MAH
of a medicinal product for human use to nominate a contact person in Denmark to represent the qualified person referred to in subsection (1)(vii).
Bivirkninger ved lægemidler
§ 53. Indehaveren af en markedsføringstilladelse til et lægemiddel skal råde over en sagkyndig inden
for lægemiddelovervågning med bopæl i EU.
Stk. 2. Stk. 1, nr. 2, gælder ikke for lægemidler til dyr.
Stk. 3. Sundhedsstyrelsen kan, når lægemiddelovervågning gør det påkrævet, pålægge indehaveren
af markedsføringstilladelsen til et lægemiddel til mennesker at udpege en kontaktperson i Danmark
for den i stk. 1, nr. 7, nævnte sagkyndige.

Translation:
Side effects of drugs
§ 53. The holder of a marketing authorization for a medicinal product must have a
pharmacovigilance expert resident in the EU.
PCS. 2. Stk. 1, no. 2, does not apply to medicinal products for animals.
PCS. 3. The Danish Health and Medicines Authority may, when pharmacovigilance so requires,
require the holder of the marketing authorization for a medicinal product for humans to appoint a
contact person in Denmark for the person referred to in subsection (1). 1, no. 7, mentioned experts.

Registration
Not applicable

LCPPV Required
No

Comments
By default, LCPPV is not required but an Estonian-speaking contact point may be required in cases
where prescribers of the medicinal products are to be informed about the safety risks associated
with the use of medicines (direct healthcare professional communication and materials for
additional risk minimisation measures).

Legislation and Guidelines
According to regulation of the Minister of Social Affairs no. 26 (§ 4 section 4) for providing safety
information about a medicinal product and the calculation of fee payable for safety and quality
surveillance of a medicinal product, Estonian speaking contact person is required.

Registration
Not applicable

LCPPV required
No (not in practice)

Comments
According to national legislation (Medicines Act 30 c §), the Finnish Medicines Agency (Fimea) may
request the nomination of pharmacovigilance contact person at national level.

Fimea recommends the MAH to nominate a contact person for pharmacovigilance issues at national
level. The contact person does not need to hold a specific medical degree, but a good knowledge of
pharmacovigilance practices and regulatory requirements would be beneficial. If the MAH does not
nominate LCPPV, all ICSR related communication will be directed to the EU QPPV.

Fimea does not request all MAHs to nominate a contact person. Seeing that all PV communication
directed centrally to the EU QPPV or delegates is more practical, there is no good reason to appoint
an LCPPV.

Legislation and Guidelines
The medicines legislation 30 c § (3.5.2013/330) states:
Lääkealan turvallisuus- ja kehittämiskeskus voi tarvittaessa pyytää myyntiluvan,
rinnakkaistuontimyyntiluvan ja rekisteröinnin haltijaa nimeämään kansallisen tason
lääketurvatoiminnasta vastaavan yhteyshenkilön, joka raportoi lääketurvatoiminnasta vastaavalle
henkilölle.

Translation:
Fimea can request the MAH to appoint a contact person responsible for national level
pharmacovigilance activities who reports to the EU QPPV.

Registration
There is a specific form available for the contact information of the LCPPV and the EU QPPV. The
form can be sent via email to phvigi.contact@fimea.fi, by mail to Finnish Medicines Agency,
Pharmacovigilance unit, P.O.Box 55, FI-00034 Fimea, Finland or by fax to +358 29 522 3006.

LCPPV Required
Yes

Comments
According to national law, nomination of LCPPV (physician or pharmacist) who lives and works in
France, is required for each company that promotes and distributes human medicinal product(s)
(MAH or not). The LCPPV is nominated to ANSM.

For France, it is important to make the difference between the LCPPV (responsable de
pharmacovigilance, RPV) and Responsible Pharmacist (Pharmacien Responsible, PR). They can be
one and the same person, but they are not the same role.

Legislation and Guidelines
The ANSM website provides a comprehensive Q&A related to the French GVP and the LCPPV
requirements.

Est-il possible de préciser l’échéance de désignation d’un responsable de pharmacovigilance (RPV)
pour un exploitant n’ayant pas encore de produits sur le marché?

Afin d’assurer les obligations et les responsabilités qui lui incombent en matière de
pharmacovigilance, l’exploitant dispose, conformément aux dispositions de l’article R.5121-164 du
CSP, des services d’une personne de référence en matière de pharmacovigilance sur le territoire
national.

Cette personne de référence, médecin ou pharmacien, réside et exerce ses activités en France et
doit justifier d’une expérience en matière de pharmacovigilance. Elle peut être distincte (ou non) de
la personne qualifiée responsable en matière de pharmacovigilance dans l’union européenne (QPPV)
et/ou du pharmacien responsable (PR).

La désignation d’un RPV doit se faire dès qu’une entreprise exploite un médicament, conformément
aux dispositions de l’article R. 5121-164 du code de la santé publique (CSP) : « toute entreprise ou
tout organisme exploitant un médicament ou un produit mentionné à l’article R. 5121-150 dispose
des services d’une personne de référence en matière de pharmacovigilance.… ».

Translation:
Is it possible to specify the deadline for appointing a pharmacovigilance manager (RPV) for an
operator that does not yet have any products on the market?

In order to fulfill its obligations and responsibilities in terms of pharmacovigilance, the operator has,
in accordance with the provisions of article R.5121-164 of the CSP, the services of a reference person
in terms of pharmacovigilance on the national territory.

This reference person, doctor or pharmacist, resides and exercises his activities in France and must
demonstrate experience in pharmacovigilance. It may be separate (or not) from the qualified person
responsible for pharmacovigilance in the European Union (QPPV) and/or the responsible pharmacist
(PR).

The appointment of an RPV must be made as soon as a company uses a medicine, in accordance with
the provisions of Article R. 5121-164 of the Public Health Code (CSP): “any company or organization
using a medicine or a product mentioned in article R. 5121-150 has the services of a reference person
in terms of pharmacovigilance.…”.

Le RPV doit-il avoir un suppléant?
Il n’existe pas en tant que telle d’exigence de disposer d’un suppléant au RPV dans le code de la
santé publique ou les BPPV. En revanche, il est nécessaire de prévoir un système de suppléance du
RPV en cas d’absence de celui-ci (Good vigilance practices (GVP) Module I, CSP article R.5121-164,
BPPV chapitre 4 point 4.6). Le RPV doit s’assurer que son suppléant dispose de toutes les
informations nécessaires pour remplir son rôle.
Le suivi des dossiers (transmissions) entre le RPV et son remplaçant avant et après son absence doit
être formalisé.
Il n’y a pas d’obligation de communiquer à l’ANSM le nom du remplaçant du RPV en cas d’absence.

Translation:
Should the RPV have a deputy?
As such, there is no requirement to have a deputy RPV in the public health code or the BPPV. On the
other hand, it is necessary to provide a backup system for the RPV in the event of its absence (Good
vigilance practices (GVP) Module I, CSP article R.5121-164, BPPV chapter 4 point 4.6). The RPV must
ensure that their deputy has all the information necessary to fulfill their role.

The follow-up of files (transmissions) between the RPV and their deputy before and after their
absence must be formalized.

There is no obligation to communicate to the ANSM the name of the deputy of the RPV in the event
of absence.

Un EUQPPV (European qualified person for pharmacovigilance) installé en France peut-il être aussi
RPV?
Un EUQPPV peut être également RPV à condition qu’il réponde aux mêmes conditions que le RPV,
soit :
• être médecin ou pharmacien ;
• résider et exercer en France ;
• justifier d’une expérience en matière de PV.

Translation:
Can an EU QPPV (European qualified person for pharmacovigilance) installed in France also be a
RPV?

An EUQPPV can also be a RPV provided that it meets the same conditions as the RPV, i.e.:
• be a doctor or pharmacist;
• reside and practice in France;
• justify experience in terms of PV.

According to Code de la Santé Publique, article 5.5121-164:
Toute entreprise ou tout organisme exploitant un médicament ou un produit mentionné à l’article R.
5121-150 dispose en permanence des services d’une personne responsable de la pharmacovigilance
résidant et exerçant dans un Etat membre de l’Union européenne ou un Etat partie à l’accord sur
l’Espace économique européen, et justifiant de qualifications appropriées en matière de
pharmacovigilance. L’identité, la qualité et la fonction ainsi que les coordonnées de cette personne
sont communiquées au directeur général de l’Agence nationale de sécurité du médicament et des
produits de santé et à l’Agence européenne des médicaments dès sa nomination.

En outre, toute entreprise ou tout organisme exploitant un médicament ou un produit mentionné à
l’article R. 5121-150 dispose des services d’une personne de référence en matière de pharmacovigilance rattachée à la personne qualifiée responsable pour les activités de
pharmacovigilance. Cette personne de référence, médecin ou pharmacien, réside et exerce en
France et doit justifier d’une expérience en matière de pharmacovigilance. L’identité et la qualité
ainsi que les coordonnées de cette personne sont communiquées au directeur général de l’Agence
nationale de sécurité du médicament et des produits de santé dès sa nomination.

Ces personnes collaborent en vue de :
1° Rassembler, traiter et rendre accessibles à toute personne habilitée les informations portées à la
connaissance de l’entreprise ou de l’organisme exploitant le médicament ou le produit, ainsi qu’aux
personnes mentionnées à l’article L. 5122-11 qui font de l’information par démarchage ou de la
prospection pour des médicaments et des produits, et relatives aux effets indésirables suspectés
d’être dus à des médicaments ou des produits qu’exploite l’entreprise ou l’organisme ;
2° Mettre en place et gérer le système de pharmacovigilance prévu à l’article R. 5121-162 et le
système de gestion des risques prévu à l’article R. 5121-163 ;
3° Préparer et soumettre les déclarations et rapports mentionnés aux articles R. 5121-166, R. 5121-
168 et R. 5121-170 ;
4° Assurer la mise en œuvre et le suivi des études de sécurité post-autorisation ainsi que le suivi
spécifique du risque, de ses complications et de sa prise en charge médico-sociale mentionnés aux
articles R. 5121-36-1 et R. 5121-37-3 ;
5° Assurer la mise en place des procédures et le recueil des informations mentionnés au premier
alinéa de l’article R. 5121-167 et en envoyer les éléments nouveaux à la base de données
européenne ” Eudravigilance ” ;
6° Veiller à ce qu’il soit répondu, de manière complète et rapide, aux demandes du directeur général
de l’Agence nationale de sécurité du médicament et des produits de santé mentionnées au troisième
alinéa du I de l’article R. 5121-155 et aux demandes des centres régionaux de pharmacovigilance
mentionnés à l’article R. 5121-158 et des centres d’évaluation et d’information sur la
pharmacodépendance et d’addictovigilance mentionnés à l’article R. 5132-112 ;
7° Fournir au directeur général de l’Agence nationale de sécurité du médicament et des produits de
santé toute autre information présentant un intérêt pour l’évaluation des risques et des bénéfices
liés à un médicament ou à un produit, notamment les résultats tant positifs que négatifs des
recherches biomédicales et des études de sécurité et d’efficacité pour toutes les indications et
populations, qu’elles soient mentionnées ou non dans l’autorisation de mise sur le marché, ainsi que
les données concernant toute utilisation du médicament non conforme aux termes de l’autorisation
de mise sur le marché et toute information relative au volume des ventes et à la prescription pour le
médicament ou le produit concerné.

Translation:
Any company or organization operating a drug or a product mentioned in Article R. 5121-
150 permanently has the services of a person responsible for pharmacovigilance residing and
practicing in a Member State of the European Union or a State Party. to the Agreement on the
European Economic Area, and justifying appropriate qualifications in pharmacovigilance. The
identity, quality and function as well as the contact details of this person are communicated to the Director General of the National Agency for the Safety of Medicines and Health Products and to the
European Medicines Agency upon appointment.

In addition, any company or organization operating a drug or a product mentioned in article R. 5121-
150 has the services of a pharmacovigilance reference person attached to the qualified person
responsible for pharmacovigilance activities. This reference person, doctor or pharmacist, resides and
practices in France and must prove that he has experience in pharmacovigilance. The identity and
position as well as the contact details of this person are communicated to the Director General of the
National Agency for the Safety of Medicines and Health Products upon appointment.

These people work together to:
1 ° Gather, process and make accessible to any authorized person the information brought to the
attention of the company or body operating the drug or product, as well as to the persons mentioned
in Article L. 5122-11 who do information by canvassing or prospecting for drugs and products, and
relating to undesirable effects suspected to be due to drugs or products operated by the company or
organization;
2 ° Set up and manage the pharmacovigilance system provided for in article R. 5121-162 and the risk
management system provided for in article R. 5121-163 ;
3 ° Prepare and submit the declarations and reports mentioned in Articles R. 5121-166, R. 5121-168
and R. 5121-170 ;
4 ° Ensure the implementation and monitoring of post-authorization safety studies as well as the
specific monitoring of the risk, its complications and its medico-social care mentioned in Articles R.
5121-36-1 and R. 5121-37-3 ;
5 ° Ensure the implementation of the procedures and the collection of the information mentioned in
the first paragraph of article R. 5121-167 and send the new elements to the European database
“Eudravigilance”;
6 ° Ensure that requests from the Director General of the National Agency for the Safety of Medicines
and Health Products mentioned in the third paragraph of I of Article R. 5121- 155 and at the requests
of the regional pharmacovigilance centers mentioned in article R. 5121-158 and the evaluation and
information centers on drug dependence and addictovigilance mentioned in article R. 5132-112 ;
7 ° Provide the Director General of the National Agency for the Safety of Medicines and Health
Products with any other information of interest for the assessment of the risks and benefits
associated with a medicinal product or a product, in particular the results both positive and negative
biomedical research and safety and efficacy studies for all indications and populations, whether or
not they are mentioned in the marketing authorization, as well as the data concerning any use of the
medicinal product that does not comply with the terms of the marketing authorization and any
information relating to the volume of sales and the prescription for the drug or product concerned.

Registration
The declaration of the LCPPV or reference person for pharmacovigilance in France (RPV) is submitted
by using an online form. Information about the submitted appointment can be asked by email declarationrpv@ansm.sante.fr or by phone 01 55 87 37 14.

LCPPV Required
Yes

Comments
The LCPPV in Germany is called “Stufenplanbeauftragter” or officer of the graduate plan (graduated
plan officer).

In Germany, it is worth noting that there are several regulatory authorities that might have to be notified of the appointment of the LCPPV. Two country-wide ones: BfArM (“traditional” medicinal products), Paul-Ehrlich-Institut, PEI (vaccines, blood preparations, gene therapeutics etc.). Then, the regional authorities of the states (Regierungspräsidium), which applies if the marketing authorization holder is located in Germany.

Legislation and Guidelines
The role of the LCPPV is defined in §63a of the German Drug Law (AMG) and their responsibility related to product complaints and recalls is described in §19 of the ordinance on GMP:

Graduated plan officer

(1) Anyone who, in his/her capacity as a pharmaceutical entrepreneur, places finished medicinal
products that are medicinal products under the terms of section 2 (1) or subsection (2) no. 1 on the
market, must appoint a qualified person who is resident in a Member State of the European Union,
who has the required expert knowledge and the reliability necessary for exercising his/her function
(graduated plan officer) to set up and manage a pharmacovigilance system and to collect and
evaluate notifications on medicinal product risks that have become known and co-ordinate the
necessary measures. Sentence 1 does not apply to persons who do not require a manufacturing
authorisation pursuant to section 13 (2) sentence 1 nos. 1, 2, 3, 5 or subsection (2b). The graduated
plan officer is responsible for meeting the obligations to notify insofar as they concern medicinal
product risks. He/she must also ensure that additional information for the evaluation of the riskbenefit profile of a medicinal product, including his/her own evaluations, are sent immediately and
in full, if requested by the competent higher federal authority. The details are stipulated by the
Ordinance on the Manufacture of Medicinal Products and Active Substances. Persons other than
those specified in sentence 1 are not authorised to perform the duties of the graduated plan officer.

(2) The graduated plan officer may be a qualified person pursuant to section 14 or a responsible
person pursuant to section 20c at the same time.

(3) The pharmaceutical entrepreneur must notify the competent authority and the competent
higher federal authority about the identity of the graduated plan officer and must make notification
of any change beforehand. In the case of an unforeseen change in the person of the graduated plan
officer, notification is to be made immediately.

Product complaints and recalls

(1) The Graduated Plan Officer is responsible for ensuring that all reports of drug risks that have become known are collected according to a written or electronic procedure and that all complaints are systematically recorded. In this context, the immediate review of the reports must be initiated, and an assessment then made as to whether there is a drug risk, how serious it is and what measures are required to avert the risk. The necessary measures are to be coordinated and brought to the knowledge of the qualified person according to § 14 of the Medicines Act so that they can take the necessary measures, if necessary, especially if it could be a quality problem. The effectiveness of the procedures must be checked regularly

(2) The person responsible for the graduated plan must inform the competent authority immediately of any defect that could lead to a recall or an unusual restriction on distribution and must also state the countries to which the medicinal product was shipped or exported. In addition, the authority must also be informed immediately of any suspicion of counterfeit medicinal products or active ingredients; in the case of medicinal products intended for human use, the marketing authorization holder must also be informed.

(3) The Graduated Plan Officer must fulfil the notification obligations under the Medicines Act insofar as they relate to drug risks. The reporting obligations according to § 14 of the GCP regulation in the version valid on the day before it expires according to Article 13 paragraph 4 of the Fourth Act amending pharmaceutical law and other regulations of December 20, 2016 (Federal Law Gazette I p. 3048) remain unaffected.

(4) Paragraph 1 applies accordingly to investigational medicinal products. The phased plan officer is responsible for ensuring that, in cooperation with the sponsor, complaints are systematically recorded and checked and that effective systematic precautions are taken so that further use of the investigational medicinal products can be prevented if this is necessary. Any defect that could lead to a recall or an unusual restriction of distribution must be documented and investigated, and the competent authority must be informed immediately and at the same time it must be stated to which test centers within or outside the scope of the Medicines Act the investigational medicinal product was delivered. If the investigational medicinal product is an approved medicinal product,

(5) The Graduated Plan Officer must keep records of the content of the reports, the type of review and the knowledge gained, the result of the evaluation, the coordinated measures, and the notifications.

(6) The graduated plan representative should be independent of the sales or distribution units and can only be represented by persons who have the expertise under Section 63a paragraph 1 sentence 1 of the Medicines Act, and must be in the area of application of the Medicines Act or in another reside and operate in a Member State of the European Union.

(7) Insofar as a pharmaceutical entrepreneur places products other than those mentioned in Section 63a (1) sentence 1 of the Medicines Act on the market, he/she must commission an appropriate person to carry out the duties of the Graduated Plan Officer. The correspondingly commissioned person is responsible for compliance with the obligations under paragraphs 1 to 5. Product complaints and recalls

(8) The pharmaceutical entrepreneur must ensure that all reports of medicinal product risks and complaints received by the company, as well as information for the assessment of the risk-benefit ratio of a medicinal product, are immediately communicated to the phased plan officer or the correspondingly authorized person pursuant to paragraph 7 sentence 1 will.

(9) Paragraphs 1 to 3 and 5 to 8 apply accordingly to auxiliary preparations within the meaning of Article 2 paragraph 2 numbers 8 and 10 of Regulation (EU) No. 536/2014.

BfArM Guidance on Stufenplanbeauftragter

The national competent authority provides information about the requirements and guidance on their website.

According to § 63a AMG, a Graduated Plan Officer (who is equivalent to the EU QPPV ) for national approvals and approvals from DCP or MRP procedures is responsible for the area of application of the AMG at the competent authority (state authority) and at the competent higher federal authority (Federal Institute for Drugs) and medical devices and/or to the Paul-Ehrlich-Institut if necessary).

The duties of the Graduated Plan Officer are defined in the AMG and in the Ordinance on the Production of Drugs and Active Substances (AMWHV). Due to the specifications in the AMWHV the tasks of the Graduated Plan Officer include additional obligations compared to the EU QPPV ( e.g. systematic recording of complaints and information of the competent authority about every defect that could lead to a recall or to an unusual restriction of sales)

Graduated Plan Officer must be sufficiently knowledgeable; a specific proof of knowledge is not (or no longer) required. The person must have sufficient professional qualifications to ensure compliance with the relevant regulations, in particular the company pharmacovigilance system.

This qualification can be acquired through professional training and practical experience. The professional qualification is assessed on a case-by-case basis and should be based on the product portfolio of the pharmaceutical company and the assessment of the possible drug risks associated with it (§ 19 Para. 1 AMWHV). Further details on this must be agreed with the competent state authorities.

There are no language requirements in the AMG. However, since communication with the authorities is predominantly in German, the Graduated Plan Officer, unless he speaks German himself, must have 24-hour access to a suitably qualified person.

Graduated Plan Officer can also be EU QPPV, an additional report by the phased plan officer is required.

The notification of the Graduated Plan Officer according to § 63a para. 3 AMG takes place via the PharmNet.Bund portal “Notification of the graduated plan officer”.

BfArM LCPPV FAQ

To see detailed answers from the national competent authority for questions related to the above legal requirements and guidance, see the FAQ on the Graduated Plan Officer.

Registration

To appoint the LCPPV in Germany to BfArM, the company should register through the PharmNet.Bund registration site. The reporting portal is used to report graduated plan officers, deputies, change reports of persons or contact details, as well as deregister the named persons.

If the marketing authorization holder is located in Germany, they should find out what the requirements of the state authority are, and register the Stufenplanbeauftragter with them.

LCPPV Required
Yes

Comments
Referring to the below described legislation, the Greek national competent authority EOF has stated
in the EMA document that local qualified person for pharmacovigilance in Greece is appointed by
the EU QPPV, for human medicinal products. This person should have an excellent knowledge of
English, a degree in Pharmacy, Medicine, Biochemistry, Biology, Chemistry, Dentistry or Nursing, 2
years of experience in pharmacovigilance and they should not be related to the marketing or
promotion departments.

Legislation and Guidelines
Ministerial Decree no. Δ.ΥΓ3α/Γ.Π. 32221 ΦΕΚ 1049/29-04-2013:
ρθρου 11 παράγραφος 1. 1α. Ο κάτοχος της άδειας κυκλοφορίας είναι υπεύ− θυνος για την
κυκλοφορία του φαρμάκου στην αγορά. Ο ορισμός αντιπροσώπου δεν απαλλάσσει τον κάτοχο της
αδείας κυκλοφορίας από την κατά νόμο ευθύνη. Ο τοπικός αντιπρόσωπος ευθύνεται αυτοτελώς και
παραλ− λήλως με τον κάτοχο της άδειας κυκλοφορίας. 2. Η άδεια που αναφέρεται στην παράγραφο
1 του παρόντος άρθρου, απαιτείται επίσης για τις γεννήτριες ραδιονουκλιδίων, kit και
ραδιοφάρμακα, πρόδρομους ραδιονουκλιδίων, καθώς επίσης και για βιομηχανικώς παραγόμενα
ραδιοφάρμακα.

Translation:
1a. The Marketing Authorization Holder is responsible for the marketing of the medicinal product.
The appointment of a representative does not relieve the holder of the marketing authorization from
the statutory liability. The local representative is responsible independently and in parallel with the
marketing authorization holder.
2. The authorization referred to in paragraph 1 of of this Article is also required for generators
radionuclides, kit and radiopharmaceuticals, precursors radionuclides, as well as for industrial
radiopharmaceuticals produced.

Registration
To appoint the LCPPV, their contact details are sent via email to adr@eof.gr. The nomination letter
should include:
• Full name
• Qualification (see Comments)
• Short CV• Telephone number for communication (company’s and 24-hour availability)
• Fax number
• Email.

LCPPV Required
Yes

Comments
LCPPV must be appointed if the EU QPPV is located outside of Hungary. This contact person has to
report to the EU QPPV. The LCPPV shall have a degree in life sciences, chemist or chemical
engineering and has to be trained in pharmacovigilance.

Legislation and Guidelines
According to the NCA website, the Hungarian Decree 15/2012 (VIII. 22.) of the Ministry of Human
Resources on the Pharmacovigilance of Medicinal Products for Human Use contains the following
requirements for the LCPPV:

• Appointment of a local pharmacovigilance contact is required if the EU QPPV does not reside
in Hungary.
• The local pharmacovigilance contact reports to the EU QPPV.
• The local pharmacovigilance contact must meet the following requirements:
o Holds a degree in life sciences, chemistry, or chemical engineering
o Has been adequately trained on the reporting requirements to the EU-QPPV
§ This training is provided or acknowledged by the marketing authorisation
holder.

The marketing authorization holder must notify OGYÉI of the appointment or any changes of the EU
QPPV and the local pharmacovigilance contact person, including their contact information.

1. How should OGYÉI be notified on the person and contact details of the EU QPPV and the local
pharmacovigilance contact? What documents should be submitted?
MAHs must notify the Institute about the appointment or any changes of the EU QPPV and the local
pharmacovigilance contact person, including their contact information via an electronic business
portal (Cégkapu). The notification should be submitted on the day of launch of the activity, at latest,
and copies of documents confirming qualification should be attached (latter requirement does not
apply if the EU QPPV is residing/established outside Hungary). Compliance with all other
requirements specified by the Decree is investigated by OGYÉI during pharmacovigilance
inspections.

2. When should the local pharmacovigilance contact be appointed?
As the scope of the Decree covers medicinal products used in the territory of Hungary; therefore,
the local pharmacovigilance contact should generally start his/her activity simultaneously with the
launch of the product to the Hungarian market. The local pharmacovigilance contact should be
employed as long as the marketing authorisation(s) of the concerned medicinal product(s) is (are)
valid in Hungary.It may occur in certain instances that the medicinal product has not been launched in Hungary yet;
nevertheless, patients have already been receiving it. Appointment of the local pharmacovigilance
contact should be considered in this scenario on a case-by-case basis.

3. Should the local pharmacovigilance contact reside in Hungary?
Appointment of a local pharmacovigilance contact is required if the EU QPPV is not residing in
Hungary. Consequently, the local pharmacovigilance contact should reside in Hungary.

4. Should the EU QPPV residing in Hungary or the local pharmacovigilance contact speak
Hungarian?
A requirement placed by the Decree on the EU QPPV residing/established in Hungary is the
knowledge on pharmacovigilance systems, and the ability to operate them. This obligation includes
the handling of pharmacovigilance data originating from the territory of Hungary, i.e. collection,
scientific assessment and management of such data in line with the rules of Hungarian public
administration. To successfully comply with these requirements, a good command of the Hungarian
language is essential. If the EU QPPV does not reside in Hungary, the local pharmacovigilance
contact, as set out in the Decree, should assist the EU QPPV to comply with its legal obligations in
terms of managing pharmacovigilance data originating from the territory of Hungary. Consequently,
thorough command of the Hungarian language is expected also from the local pharmacovigilance
contact.

5. What are the tasks of the local pharmacovigilance contact?
Tasks of the local pharmacovigilance contact are not specified item by item in the Decree; the
pharmacovigilance legislation establishes tasks and obligations only for the MAH. Nevertheless,
when specified in the Decree, the MAH should rely on the services of a local pharmacovigilance
contact, in terms of fulfilment of pharmacovigilance activities (including communication with OGYÉI)
concerning medicinal products used in Hungary. The delegation of tasks should be based on a formal
agreement between the MAH and the local pharmacovigilance contact. Nevertheless, the
responsibility for complying with legal obligations and tasks will always remain with the MAH.

6. Should the local pharmacovigilance contact be available in 24 hours/day and 7 days/week
(24/7)?
The Decree does not establish such a requirement. Nevertheless, the MAH should operate its
pharmacovigilance system in full compliance with all legal obligations. Availability of the local
pharmacovigilance contact should be determined by the MAH in view of the above.

7. Should a deputy of the local pharmacovigilance contact be appointed? If yes, what requirements
should he/she comply with?

The Decree does not establish such a requirement. Nevertheless, the MAH should operate its
pharmacovigilance system in full compliance with all legal obligations. Appointment of a deputy to
the local pharmacovigilance contact should be considered by the MAH in view of the above.

Registration

MAHs must notify the Institute about the appointment or any changes of the EU QPPV and the local
pharmacovigilance contact person, including their contact information via an electronic business
portal (Cégkapu).

LCPPV Required
No

Comments
LCPPV is not required in Iceland.

Legislation and Guidelines
Not applicable

Registration
Not applicable

LCPPV Required
No

Comments
LCPPV is not required in Ireland.

Legislation and Guidelines
Not applicable

Registration
Not applicable

LCPPV Required
Yes

Comments
In the EMA document, the requirement is “No”. The comment from AIFA in the same document
states that the appointment of LCPPV in Italy is not mandatory but someone must be registered to
the national pharmacovigilance database in which all information is in Italian. If the EU QPPV knows
Italian language it is not necessary to nominate a local contact person for pharmacovigilance for
Italy.

In practice, the LCPPV is indeed required, unless the EU QPPV speaks Italian.

Legislation and Guidelines
On its website, the national competent authority AIFA provides guidance on their LCPPV
requirements and how to appoint LCPPV and register them to the local safety system:

2) For pharmaceutical companies
• Connect to the Online Services website and fill in the registration form (see “Related
Links”).
• Connect to the Network and log in with the credentials received (new ID and password). After accessing, request the activation of the functionality “Pharmacovigilance” by filling in
an electronic form similar to the previous one with the Company’s data.
• Following registration of the electronic form, the company’s legal officer shall transmit by
fax to the number 06/59784142 or by email to the address: ReteFV@aifa.gov.it, an
appointment note confirming the details of the appointed Person responsible for
Pharmacovigilance, with attached documentation proving powers of the legal
representative (e.g. copy of Company Registration Report).
• It is important to specify in the note whether the appointed Person responsible for
Pharmacovigilance plays a role in the EU QPPV because in this case it is necessary to notify
the EMA on the name by updating the European database provided for in Art. 57 of
Regulation (EC) No 726/2004.
• The note shall specify if the registration relates to the function of “local contact” for
Pharmacovigilance, indicating also the name of the EU QPPV (in this case it is not
necessary to modify the Art. 57 database).

3) Request for the substitution of the Person responsible for Pharmacovigilance registered in the
RNF

In the case of a request for replacement of the previously registered Person responsible for
Pharmacovigilance, the request for disabling the name must be included in the same note.
Once the documentation and the correct registration on the portal have been verified, AIFA
enables the user who is required to access with his/her credentials and click on the link
“pharmacovigilance” in order to complete the registration to the system
In case the residence of the Person responsible for Pharmacovigilance is outside the Italian
territory, considering that all the communications are presented exclusively in Italian, a
“declaration” signed by the legal representative shall be attached, and with this declaration the
MAH shall assume full responsibility for equipping itself with all those language interpretation
resources that may be necessary in order to comply with regulatory obligations.
4) For the Persons responsible for Pharmacovigilance already registered in the RNF
In order to be able to associate an account in RNF to a second company, the responsible will have
to access directly to the Network of Pharmacovigilance with his credentials (those of the already
associated company), fill out a new registration form in the “new profile request” section and wait
for endorsement.

Registration
For registration follow the instructions described above under Legislation and Guidelines. For the
nomination, the following documents are required:
– Nomination letter signed by the MAH representative
– Declaration letter signed by the EU QPPV
– Proof of signatory rights of the MAH representative
o Company register and copy of ID

LCPPV Required
Yes

Comments
This is a requirement based in the Latvian law. LCPPV is mandatory unless the EU QPPV resides
and works in Latvia.

Legislation and Guidelines
Regulation No. 47 Pharmacovigilance Procedures states:
15.4. nominate a contact person for pharmacovigilance issues at national level (hereinafter –
national level contact person), who resides and works in Latvia, if the responsible person does not
reside and work in Latvia. Shall immediately submit the contact details of the national level contact
person – given name, surname, address of site of operation, electronic mail address, phone number
and fax number (if such exists), also for communication outside of working hours, as well as changes
in the contact details (if any) to the State Agency of Medicines;
16. The contact person at national level about pharmacovigilance activities shall report to the
qualified person and shall act in accordance with the instructions of the qualified person.
(Amended by the 30.09.2014. CM Regulation No. 590)
71. The requirement referred to in the Article 15.4. of this Regulation for the national level contact
person to reside and operate in Latvia shall come into force on 1 July 2015.
(As formulated in the 30.09.2014. CM Regulation No. 590)

Registration
The LCPPV contact details are submitted to the Latvian NCA via email to info@zva.gov.lv.

LCPPV Required
No

Comments

LPPV is not required in Liechtenstein.

Legislation and Guidelines

The local legislation 1998.045 812.103, article 13 states that:

3) Der Pharmakovigilanz-Verantwortliche muss im Europäischen Wirtschaftsraum ansässig und tätig sein und ist für die Einrichtung und die Führung des Pharmakovigilanz-Systems verantwortlich. Der Inhaber der Genehmigung für das Inverkehrbringen übermittelt dem Amt für Gesundheit und der Europäischen Arzneimittelagentur den Namen und die Kontaktangaben des Pharmakovigilanz-Verantwortlichen. Jede Änderung dieser Daten ist umgehend zu melden.

4) Unbeschadet des Abs. 3 kann das Amt für Gesundheit die Benennung einer Kontaktperson für Pharmakovigilanz-Fragen in Liechtenstein verlangen, die dem Pharmakovigilanz-Verantwortlichen Bericht erstattet.

Translation:

3) The pharmacovigilance officer must be resident and active in the European Economic Area and is responsible for setting up and managing the pharmacovigilance system. The Marketing Authorization Holder shall provide the Health Office and the European Medicines Agency with the name and contact details of the Pharmacovigilance Officer. Any change to this data must be reported immediately.

4) Irrespective of paragraph 3, the Public Health Office may request the appointment of a contact person for pharmacovigilance issues in Liechtenstein, who will report to the pharmacovigilance officer.

Registration
Further details would be shared by the national authorities, if the registration of LCPPV was ever requested by them. In general, the Health Authorities in Liechtenstein can be reached at info.ag@llv.li

LCPPV Required
No

Comments
The EMA document states that according to the “local law on pharmacy” LCPPV may be requested
by the Lithuanian NCA. However, during our review of the legislation, we have not found such
statement in the text.

Legislation and Guidelines
Not applicable

Registration
Not applicable

LCPPV Required
Yes

Comments
The EMA document states that, according to national legislation, the nomination of an LCPPV is
required in Luxembourg.

The LCPPV should meet the following requirements:
• Should reside and carry out his/her activities in the European Union.
• Should be reachable 24 hours a day, 7 days a week.
• Should be at a minimum with documented experience in all aspects of pharmacovigilance in
order to fulfil the responsibilities and tasks of the position.
• Knowledge of languages allowing to communicate with national stakeholders is strongly
recommended: French, German, English and/or Luxembourgish.
According to the EMA document and the LCPPV registration form, these requirements are from
Grand-Ducal Regulation, as amended, of December 15, 1992 relating to the marketing of medicinal
products, Article 45.-3, however the legislation does not mention the LCPPV.
It makes sense to appoint the same person as in Belgium (if there is one already).

Legislation and Guidelines
The website of the national competent authority for Luxembourg contains a FAQ section that
provides the following information: Déclaration de la personne de référence en matière de pharmacovigilance (RPV) au niveau
national
Dans le cadre du système de pharmacovigilance, le titulaire de l’autorisation de mise sur le marché a
de façon permanente et continue à sa disposition une personne possédant les qualifications
appropriées, responsable pour la pharmacovigilance.La personne responsable pour la
pharmacovigilance, réside et exerce ses activités dans l’Union Européenne.Le titulaire de
l’autorisation de mise sur le marché communique à la direction de la Santé le nom et les
coordonnées de la personne qualifiée, ainsi que de la personne de référence en matière de
pharmacovigilance au niveau national rattachée à la personne qualifiée responsable pour les
activités de pharmacovigilance.
• Formulaire de déclaration de la personne de référence en matière de pharmacovigilance
(RPV) au niveau national (Notification of the contact person for pharmacovigilance at
national level (or local person for pharmacovigilance/LPPV))

Translation:
Declaration of the reference person for pharmacovigilance (RPV) at national level
Within the framework of the pharmacovigilance system, the marketing authorization holder has
permanently and continuously at his disposal a person with the appropriate qualifications,
responsible for pharmacovigilance. The person responsible for pharmacovigilance, resides and
exercises its activities in the European Union The marketing authorization holder communicates to
the Health Department the name and contact details of the qualified person, as well as of the
reference person for pharmacovigilance at national level Reporting to the qualified person
responsible for pharmacovigilance activities.
• Reporting Form the person of pharmacovigilance reference (RPV) nationally (Notification of
the Contact person for pharmacovigilance at national level (local or person for
pharmacovigilance / LPPV))

Registration
The LCPPV registration form is filled in and returned by email to pharmacovigilance@ms.etat.lu or by
mail to Division de la pharmacie et des médicaments, 20, rue de Bitbourg, L-1273 LuxembourgHamm, Grand Duchy of Luxembourg.

LCPPV Required
No

Comments
In the EMA document, the comment (from the NCA) is “No information available” but according to
Guidance Notes from the Maltese Medicines Authority, “the Medicines Authority may request the
nomination of a contact person for Pharmacovigilance issues at national level, reporting to the
qualified person responsible for pharmacovigilance activities. If such a contact person is requested,
this person may or may not be medically qualified. Unless specifically requested, it is the prerogative
of each company to decide on the nomination of a person for pharmacovigilance.“

Legislation and Guidelines
Guidance Notes for Pharmaceutical Companies on Pharmacovigilance Obligations for Medicinal
Products for Human Use, published in June 2020 state:
The Medicines Authority may request the nomination of a contact person for Pharmacovigilance
issues at national level, reporting to the qualified person responsible for pharmacovigilance
activities. If such a contact person is requested, this person may or may not be medically qualified.
Unless specifically requested, it is the prerogative of each company to decide on the nomination of a
person for pharmacovigilance.

Registration
The LCPPV can be nominated with a free text email notification to
postlicensing.medicinesauthority@gov.mt

LCPPV Required
Yes

Comments
The EMA document states that the Netherlands requires a pharmacovigilance contact person at
national level if the EU QPPV resides outside the Netherlands or if the QPPV does not master the
Dutch language in speech and writing.

As the requirement for this pharmacovigilance contact person at national level is not specified in the
Dutch legislation, the Health Care Inspectorate and Dutch Medicines Evaluation Board have outlined
a general guidance for such a person.

The LCPPV shall:
• report to the QPPV (reporting in this context relates to pharmacovigilance tasks and
responsibilities and not necessarily to line management)
• master Dutch language in speech and writing (this local contact person should not only act as
contact person for the national competent authorities, but may also have contact with
patients and health care professionals);
• be knowledgeable with the relevant Dutch legislation, guidelines and procedures;
• be medically qualified (basic medical training at academic level) or have access to a person
with medical training. This access shall be duly documented;
• have a good back up procedure in place in case of absence.

Legislation and Guidelines
As mentioned in the EMA document, the requirement of the LCPPV is not specified in the Dutch
legislation, but Dutch regulatory authorities have outlined a general guidance for such a person.

The national contact person for pharmacovigilance:
• acts as contact person with the authorities
• acts as contact person for patients and medical healthcare practitioners.should be appointed at the moment that a marketing authorisation holder will market a
product in the Netherlands.

Guidelines for a national contact person
The MEB and the Health and Youth Care Inspectorate (IGJ) have compiled guidelines for a national
contact person. This person:
• Should have a thorough command of both spoken and written Dutch.
• Should have knowledge of the relevant national legislation, guidelines and procedures.
• Should have a medical qualification (university medical school graduate), or have access to
someone with medical training. These arrangements must be clearly recorded.
• Should maintain contact with the QPPV concerning the range of duties related to
pharmacovigilance.
• Should have a back-up procedure in place in the event of absence.

Registration
The LCPPV is notified to the MEB using a registration form.

LCPPV Required
No

Comments
LCPPV is not required.
NoMA has a Q&A on their website which states:
The Norwegian Medicines Agency (NoMA) has not introduced any separate or additional Norwegian
requirements. In particular, the MAH is not required to have a qualified person for
pharmacovigilance (QPPV) residing in Norway.

Legislation and Guidelines
Not applicable

Registration
Not applicable

LCPPV Required
Yes

Comments
The EMA document comments from the NCA state that MAHs are required to designate an LCPPV,
the LCPPV should speak Polish and that according to Polish legislation, the person shall fulfil the
same requirements as the QPPV and shall live or have the office in Poland.

Registration needs to be performed by sending a hard copy notification letter (specific NCA form) to
the authority by mail.

Legislation and Guidelines
The Polish NCA website contains the following information:
KOMUNIKAT
PREZESA URZĘDU REJESTRACJI PRODUKTÓW LECZNICZYCH,
WYROBÓW MEDYCZNYCH I PRODUKTÓW BIOBÓJCZYCH
z dnia 1 sierpnia 2014 roku
w sprawie wskazania osoby do kontaktu w zakresie nadzoru nad bezpieczeństwem stosowania
produktu leczniczego
Prezes Urzędu, w związku z przepisem art. 36g ust 3 ustawy Prawo farmaceutyczne (Dz. U. Nr 45 poz.
271 z późn. zm.), prosi podmioty odpowiedzialne posiadające pozwolenia na dopuszczenie do
obrotu produktów leczniczych o wskazanie osoby do kontaktu w zakresie nadzoru and
bezpieczeństwem stosowania produktu leczniczego, która będzie posiadała miejsce zamieszkania lub
siedzibę na terytorium Rzeczypospolitej Polskiej.
Osoba taka znająca język polski i pracująca w naszym kraju ułatwiłaby zgłaszanie działań
niepożądanych przez pacjentów oraz fachowych pracowników opieki zdrowotnej, w tym zbieranie
wszystkich niezbędnych danych potrzebnych do oceny przypadku.
Wskazania osoby do kontaktu prosimy dokonywać w formie pisemnej, na formularzu stanowiącym
załącznik do Komunikatu, Formularz zgłoszenia powinien zostać podpisany przez osoby upoważnione
przez podmiot odpowiedzialny do reprezentowania.
W przypadku posiadania lub wyznaczenia takiej osoby informację o tym fakcie prosimy przekazać do
Urzędu Rejestracji najpóźniej do dnia 30 września 2014 roku. W przypadku wszelkich zmianach
danych kontaktowych wskazanych osób prosimy o tym fakcie niezwłocznie informować Urząd.
Załączona do komunikatu tabela zawiera dane, o których wskazanie Urząd prosi.
Jednocześnie Prezes Urzędu, mając na względzie zdrowie publiczne, zwraca się z prośbą do
podmiotów odpowiedzialnych o rozważenie możliwości umieszczenia danych ww. osoby na stronie
internetowej podmiotów odpowiedzialnych lub przedstawicieli podmiotów odpowiedzialnych.

Translation:
ANNOUNCEMENT
PRESIDENT OF THE MEDICAL PRODUCTS REGISTRATION OFFICE,
MEDICAL DEVICES AND BIOCIDAL PRODUCTS
of August 1, 2014
on the appointment of a contact person in the field of pharmacovigilance
The President of the Office, in connection with the provision of Art. 36g (3) of the Pharmaceutical Law
(Journal of Laws No. 45, item 271, as amended), asks the marketing authorization holders for
medicinal products to indicate a contact person for the supervision and safety of the medicinal
product, which will be had the place of residence or seat in the territory of the Republic of Poland.
Such a person who knows the Polish language and works in our country would facilitate the reporting
of adverse reactions by patients and healthcare professionals, including the collection of all necessary
data needed for case assessment.
Please indicate the contact person in writing, on the form attached to the Communication, the
application form should be signed by persons authorized by the responsible entity to represent.
If you have or appoint such a person, please provide information about this fact to the Registration
Office by 30 September 2014 at the latest. In the event of any changes to the contact details of the
indicated persons, please inform the Office immediately.
The table attached to the communication contains the data requested by the Office.
At the same time, the President of the Office, having regard to public health, asks the responsible
entities to consider the possibility of placing the above-mentioned data. persons on the website of
the responsible entities or the representatives of the responsible entities.
The legislation referred to on the URPL website states:
3. Prezes Urzędu może zwrócić się do podmiotu odpowiedzialnego z wnioskiem o wskazanie osoby
do kontaktu w zakresie nadzoru nad bezpieczeństwem stosowania produktu leczniczego,
posiadającej miejsce zamieszkania lub siedzibę na terytorium Rzeczypospolitej Polskiej, która
podlega osobie, o której mowa w ust.
1 pkt 1. Osoba do kontaktu jest obowiązana spełniać wymagania określone w ust. 2 pkt 1.

Translation:
3. The President of the Office may request the responsible entity to indicate a contact person in the
field of safety oversight a medicinal product with a place of residence or seat in the territory of the
Republic of Poland, which is subject to the person referred to in paragraph 1 point 1. The contact
person is obliged to meet the requirements specified in sec. 2 point 1.
Paragraph 1 point 1 states:
1. Podmiot odpowiedzialny, który uzyskał pozwolenie na dopuszczenie do obrotu, jest obowiązany
do:
1) wskazania osoby, do obowiązków której należeć będzie nadzór nad bezpieczeństwem stosowania
produktów leczniczych;
Translation:
1.The MAH that has obtained a marketing authorization is obliged to:
1) indication of the person responsible for supervising the safety of medicinal products;And section 2 point 1 states:
2. Osoba, o której mowa w ust. 1 pkt 1, jest obowiązana:
1) spełniać wymagania określone w art. 10 ust. 1 rozporządzenia wykonawczego Komisji (UE) nr
520/2012 z dnia 19 czerwca 2012 r. w sprawie działań związanych z nadzorem nad bezpieczeństwem
farmakoterapii, o których mowa w rozporządzeniu (WE) nr 726/2004 Parlamentu Europejskiego i
Rady i w dyrektywie 2001/83/WE Parlamentu Europejskiego i Rady;

Translation:
2. The person referred to in sec. 1, point 1, is obliged to:
1) meet the requirements set out in Art. 10 sec. 1 of the Commission Implementing Regulation (EU)
No 520/2012 of 19 June 2012 on pharmacovigilance activities referred to Regulation (EC) No
726/2004 of the European Parliament and of the Council and Directive 2001/83 / EC of the European
Parliament and of the Council;

Registration
Send the completed registration form by mail to Urząd Rejestracji Produktów Leczniczych, Wyrobów
Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, Poland.

LCPPV Required
Yes

Comments
The LCPPV in Portugal should meet the following requirements:
• Be appointed by the marketing authorisation holder (MAH)
• Located in Portugal
• Perform its pharmacovigilance functions in a permanent and continuous way
• Have appropriate training and experience in pharmacovigilance, knowledge of the
Pharmacovigilance System in place and be fluent in Portuguese language.
The Excel table and the Appointment statement mentioned in the nomination process are currently
not available on the Infarmed website. Here is a summary of the contents:

Statement:
Dear , <salutation>
Marketing authorisation holder , here represented by the EU QPPV ,
hereby notifies the INFARMED IP of the local contact person for pharmacovigilance (LCPPV) issues in
accordance with Decree-law 176/2006, August 30th (current version) and CI n.º 145/CD/8.1.6, June
25th 2013.
Please find attached the signed declaration for your records.

The EU QPPV contact details are the following:
– Name:
– Address:
– Landline/office telephone number:
– Mobile telephone (24/7):
– Fax:
– Email:

The LCPPV contact details to consider are the following:
– Name:
– Address:
– Landline/office telephone number:
– Mobile telephone (24/7):
– Fax:
– Email:

The new LCPPV is acting as such since and for the following MAH medicinal products:
Excel column headers:
• MAH
• EU QPPV
• LCPPV
• Medicinal Product name
• Strength
• Pharmaceutical form
• Process number

Legislation and Guidelines
According to the National Legislation, Decree-Law n.º 176/2006, 30 August, in the present
actualization, article n.º 170, number 5:
O titular de uma autorização de introdução no mercado notifica previamente ao INFARMED toda e
qualquer informação que pretenda transmitir ao público em geral, directamente ou através do
responsável pela farmacovigilância, sobre questões de farmacovigilância.

Translation:
The holder of a permit to enter the market notifies INFARMED in advance of any and all information
it intends to transmit to the public in general, directly or through the person responsible for
pharmacovigilance, on pharmacovigilance matters.

The circular from Infarmed to marketing authorization holders on “Contact person for
pharmacovigilance issues at national level” No. 145/CD/8.1.6 published on 25th June 2013 contains
more information about the legal requirements, requirements for the LCPPV and for the
appointment of LCPPV in Portugal.

Registration
The EU QPPV is responsible for the appropriate training and experience of the contact person and
should declare it by issuing an appropriate statement.

To appoint the LCPPV the MAH should complete the Excel file that will be sent to each MAH by the
email dam@infarmed.pt

The file should be sent along with the respective(s) statement(s) of the EU QPPV within 90
consecutive days to the email address dam@infarmed.pt

The contents of the file will be loaded directly into the Infarmed’s database. Therefore, the
information related to the EU QPPV and the LCPPV should be completed for each medicinal product,
even in case of repeated information.

LCPPV Required
No (not in practice)

Comments
Romania is one of the countries where the EMA document’s requirement does not seem to be
aligned with the comment column and the national legislation and its practical implementation.
The EMA document’s comment says: “According to national legislation (Law 95/2006 with
subsequent amendments, art.815 alin.5) the National Agency for Medicines and Medical Devices
(NAMMD) may request the nomination of pharmacovigilance contact person at national level for
national pharmacovigilance aspects who should report the activity to EU QPPV level.”
However, Article 815 is about advertising of medicinal products and the LCPPV requirement is
described under Article 830.
Either way, the NAMMD may request the appointment of an LCPPV, but it does not happen in
practice.

Legislation and Guidelines
The national Law 95/2006, Article 830, states:
(4) The qualified person referred to in under (3) a) shall reside and operate in the EU and should be
responsible for the establishment and maintenance of the pharmacovigilance system. The marketing
authorisation holder shall submit the name and contact details of the qualified person to the
NAMMD and to the European Medicines Agency.
(5) Notwithstanding the provisions of paragraph (4), the NAMMD may require nomination of a
contact person for pharmacovigilance issues at national level reporting to the qualified person
responsible for pharmacovigilance activities.

Registration
Not applicable

LCPPV Required
Yes

Comments
The EMA document states that according to the national legislation (the act 362/2012, §68, art.13)
SUKL can require the MAH to nominate an LCPPV for Slovakia. It should be noted that the correct
legislative reference is 362/2011, §68, art.14.

Requirements for the LCPPV in Slovakia are:
• Good knowledge and skills of pharmacovigilance issues
• Knowledge of relevant legislation and guidelines
• Ability to communicate in Slovak or Czech language
• The premises for this person can be outside of Slovakia, but pharmacovigilance activities
have to be applied in Slovakia.

It makes sense to use the same contact person for both The Czech Republic and Slovakia.

Legislation and Guidelines
According to the law on medicines and medical devices 362/2011, §68, art.14:
Držiteľ registrácie humánneho lieku je povinný určiť osobu zodpovednú za dohľad nad bezpečnosťou
humánnych liekov s bydliskom v niektorom členskom štáte a kontaktnú osobu pre dohľad nad
bezpečnosťou humánnych liekov v Slovenskej republike, ktorá je podriadená osobe zodpovednej za
dohľad nad bezpečnosťou humánnych liekov. Držiteľ registrácie humánneho lieku oznámi štátnemu
ústavu a agentúre meno, priezvisko a kontaktné údaje o týchto osobách.

Translation:
The holder of a marketing authorization for a medicinal product for human use is obliged to
designate a person responsible for supervising the safety of medicinal products for human use
residing in a Member State and a contact person for supervising the safety of medicinal products for
human use in the Slovak Republic. The holder of the marketing authorization of a medicinal product
for human use shall notify the state institute and the agency of the name, surname and contact
details of these persons.

Registration
Registration form is provided by SUKL (C. Nominated (contact) person for pharmacovigilance). The
table should be completed in Slovak. The table should be filled in and sent as an attachment to an
email with subject: “Oznámenie kontaktnej osoby pre farmakovigilanciu” or “Notification of
nominated person for pharmacovigilance” to the email address: pharmacovigilance@sukl.sk

LCPPV Required
No (not in practice)

Comments
According to the EMA document, in the new Slovenian legislation which implements the new PhV
regulation, it is written that it is possible but not obligatory to have an LCPPV in Slovenia. JAZMP has
the possibility to require LCPPV for individual cases.

Legislation and Guidelines
The Medicinal Products Act, Article 133 (duties of the marketing authorization holder), 6 states:
Če imetnik dovoljenja za promet z zdravilom nima sedeža v Republiki Sloveniji, lahko poleg
odgovorne osebe določi tudi kontaktno osebo za farmakovigilanco v Republiki Sloveniji, ki ima
izobrazbo medicinske, veterinarske ali farmacevtske smeri druge stopnje oziroma raven izobrazbe, ki
v skladu z zakonom ustreza tej stopnji in je ustrezno usposobljena. Kontaktno osebo za
farmakovigilanco imenuje tudi, če to zahteva JAZMP in o tem izda sklep. Kontaktna oseba je lahko
poslovni s sedežem v Republiki Sloveniji ali posameznik s stalnim ali z začasnim prebivališčem v
Republiki Sloveniji, ki izvaja farmakovigilančne dejavnosti za potrebe enega ali več poslovnih
subjektov iz prvega in tretjega odstavka 20. Člena tega zakona oziroma enega ali več poslovnih
subjektov, ki so imetniki dovoljenja za vnos oziroma uvoz zdravil.

Translation:
If the marketing authorization holder is not established in the Republic of Slovenia, they may, in
addition to the responsible person, also designate a contact person for pharmacovigilance in the
Republic of Slovenia who has a medical degree, veterinary or pharmaceutical courses of the second
level or the level of education that corresponds to this level in accordance with the law and is suitably
qualified. They also appoint a pharmacovigilance contact person if requested by the JAZMP and
issues a decision to that effect. The contact person may be a business entity established in the
Republic of Slovenia or an individual with permanent or temporary residence in the Republic of
Slovenia performing pharmacovigilance activities for the needs of one or more business entities
referred to in the first and third paragraphs of Article 20 of this Act or one or more business entities,
who are holders of a permit for the import or import of medicinal products.

Registration
Not applicable

LCPPV Required
Yes

Comments
LCPPV in Spain is required.

Legislation and Guidelines
LCPPV is required in Spain according to Royal Decree 577/2013, Article 14:
Artículo 14. Persona de contacto de farmacovigilancia.
1. El titular de la autorización de comercialización deberá disponer en España, de manera
permanente y continua, de una persona de contacto en materia de farmacovigilancia, y comunicará
a la Agencia Española de Medicamentos y Productos Sanitarios los datos de contacto de la misma a
través de un sistema electrónico que se proveerá a tal efecto. La persona designada deberá poseer
la experiencia y formación adecuadas para la realización de sus funciones. La Agencia Española de
Medicamentos y Productos Sanitarios mantendrá una base de datos de estas personas, que estará
disponible para los órganos competentes de las comunidades autónomas.
2. La persona de contacto de farmacovigilancia asistirá a la persona cualificada responsable de
farmacovigilancia europea referida en el artículo 8.3 en aquellas funciones que se le encomienden y
colaborará en las siguientes funciones:
a) Recopilar, la información sobre todas las sospechas de reacciones adversas de las que tenga
conocimiento el personal de la empresa, con el fin de que dicha información se incorpore en el
registro referido en el apartado 1 del artículo 9, garantizando que:
1.º Se obtiene información exacta y verificable que permita la evaluación científica de las
notificaciones de sospechas de reacciones adversas.
2.º Se recabe información de seguimiento sobre estas notificaciones.
3.º En colaboración con el Sistema Español de Farmacovigilancia se detecten casos duplicados de
sospechas de reacciones adversas.
4.º Se identifiquen adecuadamente las sospechas de reacciones adversas que el notificador haya
informado que son consecuencia de un error de medicación.
b) Trasmitir a la persona responsable de farmacovigilancia de la Unión Europea referida en el
artículo 8.3 cualquier solicitud de información adicional de la Agencia Española de Medicamentos y
Productos Sanitarios necesaria para poder evaluar los beneficios y riesgos de un medicamento y dar
respuesta a cualquier informaciónque la Agencia Española de Medicamentos y Productos Sanitarios
le solicite relativa al volumen de ventas o de prescripciones del medicamento de que se trate en
España.
c) Actuar como punto de contacto para proporcionar información a la Agencia Española de
Medicamentos y Productos Sanitarios acerca de la ejecución en España de las medidas reguladoras
adoptadas por razones de seguridad, así como de las acciones realizadas en España relativas a lo
establecido en el plan de gestión de riesgos.
d) Establecer los procedimientos necesarios que garanticen el correcto funcionamiento de las
actividades locales de farmacovigilancia.
e) Actuar como persona de contacto para las inspecciones de farmacovigilancia realizadas en
España.
f) Cooperar con los centros autonómicos de farmacovigilancia facilitando toda la información de que
disponga en relación con las notificaciones de sospechas de reacciones adversas a medicamentos.

Translation:
Article 14. Pharmacovigilance contact person.
1. The marketing authorisation holder shall have in Spain, on a permanent and continuous basis, a
contact person in the field of pharmacovigilance, and shall communicate to the Spanish Agency for
Medicines and Health Products the contact details of the same through an electronic system that will
be provided for this purpose. The designated person shall possess the appropriate experience and
training for the performance of his or her duties. The Spanish Agency for Medicines and Health
Products will maintain a database of these people, which will be available to the competent bodies of
the autonomous communities.
2. The pharmacovigilance contact person shall assist the qualified person responsible for European
pharmacovigilance referred to in Article 8.3 in those tasks entrusted to him or her and shall assist in
the following tasks:
(a) Collect information on all suspected adverse reactions known to the staff of the undertaking, so
that such information is entered in the register referred to in Article 9(1), ensuring that:
1º Accurate and verifiable information is obtained that allows the scientific evaluation of the reports
of suspected adverse reactions.
2. Follow-up information is collected on these notifications.
3.º In collaboration with the Spanish Pharmacovigilance System, duplicate cases of suspected adverse
reactions are detected.
4º Suspicions of adverse reactions that the notifier has reported as a result of a medication error are
adequately identified.
b) Transmit to the person responsible for pharmacovigilance of the European Union referred to in
article 8.3 any request for additional information from the Spanish Agency for Medicines and Health
Products necessary to be able to evaluate the benefits and risks of a medicine and respond to any
information that the Spanish Agency for Medicines and Health Products requests regarding the volume
of sales or prescriptions of the medicine in question in Spain.
c) Act as a point of contact to provide information to the Spanish Agency for Medicines and Health
Products about the execution in Spain of the regulatory measures adopted for safety reasons, as well
as the actions carried out in Spain related to the provisions of the risk management plan.
(d) Establish the necessary procedures to ensure the proper functioning of local pharmacovigilance
activities.
e) Act as a contact person for pharmacovigilance inspections carried out in Spain.
f) Cooperate with the regional pharmacovigilance centres by providing all the information available to
them in relation to the notifications of suspected adverse reactions to medicinal products.

Registration
The appointment of the LCPPV in Spain is notified using an online form on the AEMPS website
following the user manual for pharmaceutical industry.

LCPPV Required
No

Comments

LCPPV is not required in Sweden.

Legislation and Guidelines
Not Applicable

Registration
Not Applicable

Outside of EEA, it’s worth noting that contact persons are required in Switzerland and United
Kingdom (or guidance, in case of MHRA).