Obligations of participants in the pharmacovigilance system are specified in the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14 and 66/19), Rules on pharmacovigilance of medicinal products for use in veterinary medicine (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 53/06 and 17/14 – ZZdr-2) and in Rules on pharmacovigilance of medicinal products for use in human medicine (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 57/14 and 27/17), including the tasks of the Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (below: JAZMP) in the field of pharmacovigilance.
Article 134 of ZZdr-2 specifies that JAZMP supervises the implementation of the pharmacovigilance system at marketing authorisation holders of medicinal products, and at other participants in the pharmacovigilance system.
Pharmaceutical inspectors conduct inspections in their field of competence in the Republic of Slovenia as routine, for cause (triggered), and follow-up inspections, which may also be unannounced. The aim of inspection is to determine and ensure the compliance with the requirements in the field of pharmacovigilance, as laid down at European Union level.
The frequency of routine inspection is determined according to the risk assessment in accordance with paragraph two of Article 170 of ZZdr-2.
Based on ZZdr-2 and in accordance with Module III of Good pharmacovigilance practice (below: GVP), which contains directives regarding the implementation of inspection in the field of pharmacovigilance, JAZMP must plan and implement inspection on the basis of risk assessment in cooperation with the European Medicines Agency (below: EMA). Good pharmacovigilance practice (GVP) contains directives on the implementation of pharmacovigilance activities in accordance with Article 108.a of the Directive 2001/83/EC. GVP directives are published on the European Medicines Agency website:
According to GVP Module III inspections should be performed on a risk based approach at the marketing authorisation holders of medicinal products, before or after the marketing authorisation for medicinal products was granted, and at other person liable that perform pharmacovigilance activities in whole or in part, in the name of or in connection with the marketing authorisation holder.
For the purpose of preparing a risk assessment, which forms the basis for inspection planning (selection of persons liable), JAZMP prepared a pharmacovigilance questionnaire in 2015, which was published at the JAZMP website in the form of a Microsoft Excel file. Persons liable were asked at the time to complete the questionnaire, which relates to the implementation of pharmacovigilance activities.
Relevant persons liable to fill in a questionnaire received a letter wherein JAZMP invited them to submit the completed questionnaire. Such relevant person liable were: person liable with an address in the Republic of Slovenia who hold a marketing authorisation for medicinal product (MAH) or a temporary marketing authorisation for a medicinal product, holders of the wholesale distribution authorization (wholesalers), holders of manufacturing authorization with importation permit (importers), marketing authorization holders for parallel distribution (parallel importers), marketing authorization holders for compassionate drug use and person liable (contractors) that conduct pharmacovigilance activities in whole or in part or in connection with the marketing authorisation holder.
Legal basis:
- Article 134 of the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14 and 66/19),
- Rules on pharmacovigilance of medicinal products for use in human medicine (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 57/14 and 27/17)
- Good pharmacovigilance practices (GVP) Good pharmacovigilance practices
- Rules on pharmacovigilance of medicinal products for use in veterinary medicine (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 53/06 and 17/14 – ZZdr-2),
- Volume 9b Guidelines on Pharmacovigilance of veterinary medicinal products.
