GDP Guidelines now also valid in Switzerland

Recommendation

6/7 November 2024

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On 7 March 2013 the Guidelines on Good Distribution Practice of medicinal products for human use were published in the official journal of the European Commission. They became effective in the EU Member States six months after publication - on 8 September 2013.

It was unclear for a long time what validity these Guidelines have in the non-EU state Switzerland. Within the framework of the agreement between the Swiss Confederation and the European Community on Mutual Recognition Agreements (MRA) Switzerland has committed to respect European principles of law as far as they include GMP regulations. Thus, the GMP regulations of the relevant directives such as 2001/83/EC also apply.

For the EU-GDP Guidelines, the need for action was determined by the Swiss Federal Office of Public Health (Bundesamt für Gesundheit, BAG), and it was recommended that in particular internationally active companies with corresponding Swissmedic approval - and in light of the current state of science and technology (cf. Art. 3 of the Swiss law on pharmaceutical and medicinal products - HMG, SR 821.21) ..., - should already implement the new GDP Guidelines as far as the current applicable GDP Guidelines defined in Annex 2 of the AMBV are still met.

Now, through the adaptation of Annex 2 of the Medicinal Products Approval Regulation (AMBV), the Federal Department of the Interior has implemented the EU-GDP Guidelines. According to the BAG they fall under the MRA. The adjustments were made in a shortened procedure and become effective on July 1, 2015 - with a planned implementation period of six months.

In the BAG release it is stated: "In order to satisfy the different conditions..., implementation in Swiss law is to proceed in a way that keeps the expenditures for small and medium-sized enterprises (SMEs) ...  to a reasonable level. If this should end up necessitating further amendments to therapeutic products legislation, these would be made as part of the implementing provisions for the revised Therapeutic Products Act." The implementation as well as the definition of possibly needed technical directives is now up to the SwissMedic.