H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.

MAGYAR

EU-QPPV and Local Pharmacovigilance Contact

Decree 15/2012 (VIII. 22.) of the Ministry of Human Resources on the Pharmacovigilance of Medicinal Products for Human Use (hereafter: Decree) provides as follows for the Qualified Person for Pharmacovigilance (EU-QPPV) residing or established in Hungary, and for the Local Pharmacovigilance Contact:

EU-QPPV

If the EU-QPPV is residing/established in Hungary, the EU-QPPV must meet the following requirements:

· Holds a degree in medicine, pharmacy, dentistry or biology,

· Possesses the knowledge on pharmacovigilance systems, and the ability to operate them,

· Has at least 3 years of professional experience in pharmacovigilance.

If the EU-QPPV is not a medical doctor, the marketing authorisation holder (MAH) must ensure the availability of a medical doctor, the name and contact details of whom must be documented in the pharmacovigilance system master file.

Local (Hungarian) Pharmacovigilance Contact

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:

· Holds a degree in life sciences, chemistry, or chemical engineering,

· Has been adequately trained on the reporting requirements to the EU-QPPV, and this training had been provided or acknowledged by the marketing authorisation holder.

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.

Appointment and changes in the person or contact information of the EU-QPPV should be updated in the Article 57 database. However, submission of a variation to the Authority is not required.

Guidance to MAHs is provided below in a Question and Answer format about further requirements concerning the EU-QPPV and the local pharmacovigilance contact.

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.

Last updated: 2018.02.06 17:07