Arrangement of GDP Inspections
The National Public Health and Pharmacy Center (NNGYK), as the competent authority responsible for the supervision of the wholesale distribution of medicinal products, ensures through its inspectors that wholesale distributors comply with the applicable legal requirements.
Purpose of GDP Inspections
Where a legal person applies for a wholesale distribution authorisation for medicinal products, the granting of the authorisation is subject to a successful on-site GDP inspection.
Detailed information in Hungarian on the procedures for the granting of new wholesale distribution authorisations and for the variation of existing authorisations is available on this website:
https://ogyei.gov.hu/gyogyszer_nagykereskedelem
Following the granting of the wholesale distribution authorisation, the wholesale distributor is subject to regular on-site inspections by the competent authority in order to continuously monitor the distributor’s activities and compliance with the applicable requirements.
The National Public Health and Pharmacy Center (NNGYK) may also conduct an unscheduled GDP inspection where a quality defect or an irregularity in the wholesale distribution of medicinal products is identified, or where significant changes occur in the circumstances relating to the wholesale distribution of medicinal products.
GDP Certificate - Validity of GDP compliance status
In the case of a GDP Certificate, the expiry of the five-year period following the date of the on-site inspection indicated in the certificate does not affect the validity of the wholesale distribution authorisation. The activities may therefore continue to be carried out in accordance with the terms of the authorisation.
According to the regulatory practice of the National Public Health and Pharmacy Center (NNGYK), which is consistent with the applicable national legislation, where a pharmaceutical wholesaler established or having an establishment in Hungary holds a valid wholesale distribution authorisation and a GDP Certificate, including where the certificate indicates an inspection date more than five years previously, and no GDP non-compliance report has been issued in respect of that wholesaler, the wholesaler’s activities may be considered to be compliant with the applicable national legislation and with the principles and requirements of Good Distribution Practice (GDP).
The list of holders of wholesale distribution authorisations issued by the National Public Health and Pharmacy Center (NNGYK) is available at the following link, under Section 12:
https://ogyei.gov.hu/egyéb_nyilvántartások_listák
The GDP Certificates issued by the National Public Health and Pharmacy Center (NNGYK), as well as GDP non-compliance reports, are recorded in the EUDRAGMDP database (https://eudragmdp.eudra.org/). The register of wholesale distribution authorisations is available on the NNGYK website; however, these authorisations are also included in the EUDRAGMDP database for information purposes.
Format of Hungarian Wholesale Distribution Authorisations for Medicinal Products for Human Use
Introduction of a New European Union Authorisation Format
The format of wholesale distribution authorisations issued by the National Directorate of Pharmacy and Nutrition (NNGYK) is aligned with the product categories set out in Annex 1 to Decree 53/2004 (VI. 2.) of the Minister of Health, Social and Family Affairs on wholesale distribution and parallel import activities relating to medicinal products, as well as with the Union template for a wholesale distribution authorisation (Union format wholesale distribution authorisation).
Wholesale distribution authorisations issued under the previous Union format will be progressively updated through subsequent variations and amendments.
The introduction of the new format does not entail any change to the scope of the authorised activities or the range of medicinal products covered by the authorisation.
The following changes are introduced with the new Union format:
- Separation and clarification of sales and transport activities. Transport activities are indicated as a separate entry under 2. Authorised wholesale distribution operations / 2.5. Transport in the new-format authorisations of wholesalers that carry out transport using their own vehicles or through outsourced arrangements and assume responsibility for the quality aspects of the transport activity.
- The categories 3.1.2 Medicinal products derived from blood and 3.1.3 Immunological medicinal products are removed. It is important to note that the removal of these categories does not reduce the scope of the authorisations. Medicinal products falling within these categories may continue to be distributed on the basis of any valid wholesale distribution authorisation issued by the NNGYK, as was the case prior to the introduction of the new format.
Authorised Medicinal Product Categories
In the Member States of the European Union, wholesale distribution authorisations may, in accordance with the national legislation of the Member State concerned, contain restrictions which may differ from one Member State to another. Hungarian wholesale distribution authorisations issued by the NNGYK distinguish exclusively between the categories listed below, with the proviso that the distribution of allopathic medicinal products is, as a general rule, covered by every authorisation.
„3.3.1. Homeopátiás gyógyszerek / Homeopathic medicinal
products
3.3.2. Radiofarmakon gyógyszerek / Radiopharmaceuticals
3.3.3. Gyógyszeranyagok / Materials for preparation of „magistral formula”
(human medicinal products)
3.3.4. Növényi és állati drogok / Plant- and animal-derived substances and
excipients
3.3.5. Orvosi gázok / Medicinal gases
3.3.6. Folyamatos ambuláns peritoniális dialízishez alkalmazott dializáló
oldatok (ún. CAPD oldatok)./ Dialysing solutions (s.c. CAPD solutions)
applying for continuous ambulant peritoneal dialysis.”
Accordingly, any authorised medicinal products falling within categories not specifically listed above (for example, allopathic medicinal products, prescription-only medicinal products, medicinal products derived from blood, immunological medicinal products, etc.) may be distributed under any wholesale distribution authorisation issued by the NNGYK, even where the relevant category is not expressly specified in the text of the authorisation.
The same principle applies to storage temperature categories. Medicinal products which are labelled as “no special storage conditions required”, “store at a temperature not exceeding 25 °C”, or “store at a temperature not exceeding 30 °C” may be distributed, with regard to their storage temperature requirements, under any wholesale distribution authorisation issued by the NNGYK (and, in the case of an authorisation covering warehousing activities, may be stored under such an authorisation), even where these storage temperature categories are not expressly specified in the text of the authorisation.
