Requirements for Nomination of a PV Contact Person

Austria

Not required (but may be requested if considered necessary)

There are no specific requirements for the local PV person in Austria that would be established by local laws.

There is no legal obligation for each Marketing Authorization Holder (MAH) to appoint a local PV person in Austria. However, according to local law (§ 75i (6) AMG), the Austrian Federal Office for Safety in Health Care (BASG) has the option to request the nomination of a PV contact person at a national level in Austria from the MAH. In practice, most of the companies nominate the local PV person in Austria voluntarily.

Belgium

Required

The local PV person in Belgium must:

• Be contactable 24 hours a day, 7 days a week.
• Carry out activities in pharmacovigilance in Belgium.
• 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 QPPV.

The article 66§2 of the Royal Decree 14/12/2066 of Belgium sets an obligation for the Marketing Authorization Holders (MAHs) to appoint a local PV contact person in Belgium and to notify his/her details to the Federal Agency for Medicines and Health Products of Belgium (FAMHP).

Bulgaria

Required

The local PV person in Bulgaria must:

• Be established in the territory of Bulgaria.

The Bulgarian law for medicinal products in human medicine in force from April 2007, last amendment from 22.12.2012, Article 191, Point 3. sets an obligation for the MAH to nominate local PV person on a national level in Bulgaria.

Croatia

Required

The local PV person in Croatia must:

• Hold an education of:
  • a Medical Doctor (MD) specialized in clinical pharmacology, or
  • a Medical Doctor (MD), or a doctor of dental medicine*, or a pharmacist*, or a master of medical biochemistry*, or a doctor of veterinary medicine*, with:
    • at least 2 years of experience in pharmacovigilance or two years of experience in his/her profession.
    • documented training in (1) in PV terminology, (2) spontaneous and solicited reporting of adverse reactions (ADRs), and (3) methods of ADR reporting, evaluation of ADRs, preparation of Individual Case Safety Reports (ICSRs), PSURs, RMPs, and DSURs.

    *If the person responsible for PV is not a medical doctor (MD), access to a medical doctor (MD) must be available and appropriately documented.

• Reside in the Republic of Croatia.
• Be available 24/7.
• Must be registered at the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) for performing ADR monitoring activities or PV activities, or must be employed by a legal person registered at HALMED for performing ADR monitoring activities or PV activities.

The Medicinal Products Act (Official Gazette No. 76/13 and 90/14; Article 3, Item 58) and Ordinance on Pharmacovigilance (Official Gazette 83/13), set a legal obligation for the MAH to appoint a contact person for PV in Croatia. In addition to the primary local PV person, a Deputy with equal qualifications is required.

Cyprus

Required

The local PV person in Cyprus must:

• Reside in Cyprus;
• Be a qualified healthcare professional or a biologist or chemist.
• Be adequately trained in pharmacovigilance.
• Be fluent in written and spoken Greek.

Based on the Article 57 of The Medicines for Human Use (Control of Quality, Supply and Prices) Law 70 (I) of 2001, The Pharmaceutical Services of Cyprus requires MAHs to appoint of a local QPPV/RPPV in Cyprus, should the EU QPPV not reside and operate in the Republic of Cyprus.

Czech Republic

Required

The local PV person in the Czech Republic must:

• Be able to communicate in Czech or Slovak language.
• Be contactable on the phone number with the Czech country calling code.
• Reside in the EU.

For human medicinal products, pursuant to Sec. 91a (3) of the Act on Pharmaceuticals and PHV-6 Guideline, the State Institute for Drug Control (SÚKL) requests the marketing authorisation holders to appoint a contact person for pharmacovigilance issues in the Czech Republic. The appointment of contact person for pharmacovigilance issues is an obligation which is imposed on all marketing authorization holders in the Czech Republic regardless of marketing status of their products.

• to collect pharmacovigilance data, or;
• to perform PASS in the Czech Republic or to participate in funding of patient support programs in Czech Republic etc.;

Denmark

Not required (but may be requested if  considered necessary)

There are no specific requirements for the local PV person in Denmark.

According to national legislation (Medicines Act § 53), the Danish Health and Medicines Authority (DHMA) 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).

Estonia

Required

The local PV person in Estonia must:

• Be fluent in Estonian.

According to the Regulation of the Minister of Social Affairs no. 26 (§ 4 section 4), Estonian speaking contact person is required when there is a need for either direct healthcare professional communication (DHPC) and materials associated with additional risk (Educational Materials) in Estonia. This person should have overview of the additional risk minimisation measures implemented for the medicinal product (including the content of the topic, the target group of the recipients, training of the recipients), should ensure the dissemination of the materials to the recipients, and have overview of the method of dissemination, content of the topic, the target group of the recipients and ensures the dissemination of the DHPC to the recipients, also must be able to answer requests of HCPs and regulatory authority.

Finland

Not required (but may be requested if considered necessary

There are no specific requirements for the local PV person in Finland.

According to national legislation (Medicines Act 30 c §), the Finnish Medicines Agency (Fimea) may request the MAH to designate a national PV contact person in Finland, who should report to the EU-QPPV.

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 the contact person, all individual case safety report (ICSR) related communication will be directed to the EU QPPV.

France

Required

The local PV person in France must:

• Be a Medical Doctor (MD) or a Pharmacist.
• Live and operate in France.
• Have experience in pharmacovigilance.

Article 5.5121-164 of the French Public Health Code (Code de la Santé Publique), imposes an obligation to nominate a local PV responsible person in France.

This function is not dependent on a marketing authorization but is mandatory for every company who promotes and distributes human medicinal products in France (independently if the company is MAH or not).

Upon his/her appointment, the persons identity, qualifications and contact details must be communicated to the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) (French: National Security Agency of Medicines and Health Products) for human medicinal products.

Germany

Required

The requirements for the local PV person in Germany (the “Stufenplanbeauftragter” / Graduated Plan Officer) are equal to those of the EU QPPV. In addition to the “Stufenplanbeauftragter”, a Deputy with equal qualifications is required, and 24/7 availability must be ensured.

There is no requirement for the Graduated Plan Officer to speak German or be a resident of Germany, theoretically, he/she can be resident of any Member State of the European Union. However, as explained by BfArM, the “Stufenplanbeauftragter” has to communicate with the BfArM and the competent authorities in the federal states (Landesbehoerden) and this communication is done almost exclusively in the German language, therefore it is almost impossible for the Graduated Plan Officer to fulfil his role without being able to speak German.

As defined by the section 63a of the German Drug Law (AMG), Germany requires the nomination of a local PV responsible person in Germany, referred to as the “Stufenplanbeauftragter” (the Graduated Plan Officer – GPO). This function is not dependent on a marketing authorization but is mandatory for every company who places finished medicinal products on the market in Germany (independently if the company is MAH or not).

The specific legal obligations of the “Stufenplanbeauftragter” are defined in the AMG and in the regulation “Arzneimittel- und Wirkstoffherstellverordnung .- AMWHV”. They are similar to those of the EU-QPPV but not identical (e.g. quality complaints in the AMWHV). Some important particularities are that:

The GPO has to be reliable (as proven by criminal record certificate);
The GPO is responsible for technical complaints and recalls;
The GPO is personally liable.

Greece

Required

• The local PV person in Greece must:
  Be fluent in Greek and English.
• Have a degree in medicine, dentistry, biology, biochemistry, chemistry, veterinary medicine, or nursing highest (Higher Education).
• 2 years of experience in pharmacovigilance.
• Not belong to or be related to the marketing or promotion departments.

Article 136 (4) of the Ministerial Decree no. Δ.ΥΓ3α/Γ.Π. 32221 ΦΕΚ 1049/29-04-2013 sets an obligation for the MAH to appoint a local qualified person for pharmacovigilance (local QPPV) in Greece.

Hungary

Required

The local PV person in Hungary must:

• Have a degree in life science or chemistry or chemical engineering.
• Be trained in pharmacovigilance (provided or acknowledged by the EU QPPV).

The Regulation of Ministry of Human Resources on pharmacovigilance of human medicinal products (15/2012) set a legal obligation for MAHs to appoint a national PV contact person in Hungary in case the residence of the responsible person for Pharmacovigilance (EU QPPV) is outside of Hungary.

Iceland

Not required

There are no specific requirements for the local PV person in Iceland.

There is no legal requirement to appoint a local PV contact person in Iceland, the EU-QPPV residing within the EEA is sufficient.

Ireland

Not required

There are no specific requirements for the local PV person in Ireland.

There is no legal requirement to appoint a local PV contact person in Ireland, the EU-QPPV residing within the EEA is sufficient.

Italy

Not required (but might be necessary)

There are no specific requirements for the local PV person in Italy.

Italy does not specifically require the nomination of a local national contact person for pharmacovigilance (LNCPP), however, either the EU-QPPV or the LNCPP must register to the Italian national pharmacovigilance database (RNF) where all information is provided only in the Italian language. Therefore, if the EU-QPPV does not know the Italian language, it may be necessary to nominate a local contact person for pharmacovigilance for Italy.

Latvia

Required

The local PV person in Latvia must:

• Reside and operate in Latvia
• Be contactable 24 hours a day, 7 days a week.

Regulation No 47 „Procedure for Pharmacovigilance” requires MAH to nominate a contact person for PV issues at a national level in Latvia if the EU-QPPV does not reside and work in Latvia. The local contact person for PV in Latvia must report to the QPPV and act following the instructions of the QPPV (reporting in this context relates to pharmacovigilance tasks and responsibilities and not necessarily to line management).

MAHs 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. The requirement to submit contact details for outside of working hours proves that local PV person must be available 24/7.

Lithuania

Not required (but may be requested if considered necessary)

There are no specific requirements for the local PV person in Lithuania.

According to local Law on Pharmacy of Lithuania, the State Medicines Control Agency (SMCA) may request the nomination of a PV contact person at a national level in Lithuania.

Luxembourg

Required

The local contact person should meet the following requirements:

• He/she should reside and carry out his/her activities in the European Union.
• He/she should be reachable 24 hours a day, 7 days a week.
• He/she 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.

Art. 45.3 of the Grand Ducal Regulation of September 10, 2012, on Pharmacovigilance, sets the requirement for Marketing Authorization Holders to nominate a reference person for PV at a national level in Luxembourg who should be linked to the EU QPPV.

Malta

Not required

There are no specific requirements for the local PV person in Malta.

There is no legal requirement to appoint a local PV contact person in Malta, the EU-QPPV residing within the EEA is sufficient.

Netherlands

Required

The local PV person in the Netherlands must:

• Be medically qualified (basic medical training at an academic level), or have access to a person with medical training (MD). This access shall be duly documented.
• Master Dutch language in speech and writing.
• Be knowledgeable with the relevant Dutch legislation, guidelines, and procedures.
• Have a good back up procedure in place in case of absence.
• Report to the QPPV (reporting in this context relates to pharmacovigilance tasks and responsibilities and not necessarily to line management).

The Medicines Evaluation Board (MEB) and Health and Youth Care Inspectorate (IGJ) of the Netherlands requires a PV contact person at a national level in the Netherlands, if the QPPV resides outside the Netherlands or if the QPPV does not master the Dutch language in speech and writing.

Norway

Not required

There are no specific requirements for the local PV person in Norway.

There is no legal requirement to appoint a local PV contact person in Norway, the EU-QPPV residing within the EEA is sufficient.

Poland

Required

The local PV person in Poland must:

• Be a resident of or have registered office in the territory of Poland;
• Be fluent in Polish.
• Sufficiently competent and appropriately qualified and trained for the performance of PV activities.
• Be medically qualified or have access to a medically qualified person (such access must be appropriately documented).

According to the Article 36g of the Polish Pharmaceutical Law gave the right to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) may request MAHs to nominate a local contact person for PV in Poland. This was requested for all MAHs along with the announcement by the President of the Office of 1st August 2014.

Portugal

Required

The local PV person in Portugal must:

• Be located in Portugal.
• Be fluent in Portuguese.
• Perform his/her PV functions permanently and continuously.
• Have appropriate training and experience in PV.

5.    Have knowledge of the PV System in place.

The Portuguese National Legislation a national law (Decreto-Lei n.º 20/2013 of 14 February, amending Decreto-Lei n.º 176/2006 of 30 August) requires to appoint a contact person for pharmacovigilance issues at a national level in Portugal, who reports to the qualified person for pharmacovigilance.

Romania

Not required (but may be requested if considered necessary)

There are no specific requirements for the local PV person in Romania.

According to the national legislation of Romania (Law 95/2006 with subsequent amendments, art.815 alin.5), the National Agency for Medicines and Medical Devices (NAMMD) may request the nomination of PV contact person in national level in Romania for national PV aspects who should report to EU QPPV.
In practice, most of the companies nominate the local PV person voluntarily.

Slovakia

Required

The local PV person in Slovakia must:

• Have good knowledge and skills of pharmacovigilance issues.
• Know relevant legislation and guidelines.
• Be able to communicate in Slovak or Czech language.
• The premises for this person can be out of Slovakia, but pharmacovigilance activities have to be applied in Slovakia.

According to the national legislation of Slovakia (act 362/2012, §68, art.14), the State Institute for Drug Control requires MAHs to nominate a contact person responsible for PV issues at a national level in Slovakia.

Slovenia

Not required (but may be requested if considered necessary)

The local PV person in Slovenia must:

• Hold a medical degree, pharmacy degree, or a veterinary degree (or a level of education, which corresponds to the law and the mentioned level of education).
• Be an individual with a permanent or temporary address in the Republic of Slovenia or a business entity established in the Republic of Slovenia.

The Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (JAZMP) can require a local PV contact person in Slovenia for individual cases. The MAHs may nominate the local PV contact person in Slovenia voluntarily, as well as the PV contact person has to be named also as per JAZMP’s request after the JAZMP issues a decision.

Spain

Required

The local PV person in Spain must:

• Have the appropriate experience and training to perform his/her duties.
• Be based in Spain.
• Must be available 24/7.

Article 14, section 1, of the Royal Decree 577/2013 only for human products of Spain sets a legal obligation for MAHs to appoint and to permanently and continuously have a contact person for PV on a national level in Spain.

Sweden

Not required

There are no specific requirements for the local PV person in Sweden.

There is no legal requirement to appoint a local PV contact person in Sweden, the EU-QPPV residing within the EEA is sufficient.

UK

Required

Local PV person must:

• Reside and operate in UK.

If QPPV resides and operates in EU/EEA, MAHs must nominate a national contact person for pharmacovigilance who resides and operates in the UK and reports to the QPPV. Once the national contact person for pharmacovigilance has been appointed, their details should be notified to the MHRA via the MHRA Submissions Portal.

Additionally Local PV person must:

• Have access to the reports of suspected ADR and to PSMF for UK authorized products.
• Be able to facilitate responses to pharmacovigilance queries raised by the MHRA, including via inspections.