EU GDP Guidelines now official in Switzerland

On 8 September 2013 the Guidelines on Good Distribution Practice of medicinal products for human use became effective in the EU Member States.

It was unclear for a long time what validity these Guidelines have in Switzerland, as a non-EU state. 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 Swiss Federal Office of Public Health (Bundesamt für Gesundheit, BAG) recommended that in particular internationally active companies with corresponding Swissmedic approval 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 the Federal Department of the Interior has implemented the EU-GDP Guidelines, through the adaptation of Annex 2 of the Medicinal Products Approval Regulation (AMBV). The adjustments became effective on July 1, 2015 - with a planned implementation period of six months.

The implementation as well as the definition of possibly needed technical directives is now up to the SwissMedic.

Ordinance for authorisation of medicinal products, update of 10 Jun 2015

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