Implementation of the revised GDP guidelines for Medicinal Products in Switzerland (2013/C 343/01)

In consequence of a new guideline concerning falsified medicines, the guidelines for Good Distribution Practice were submitted to revision. These adjusted guidelines still aim to assure the quality of all activities which concern the distribution of pharmaceutical products, but their replacement contains more stringent requirements than their former version. The enforcement of the revised guidelines in November 2013, takes a significant role in Switzerland because it falls in the scope of the bilateral agreement between Switzerland and the EU. Therefore it will be beneficial for Switzerland to adopt the new version of the guidelines in order to obtain the mutual acceptance of GMP and GDP certificates between Switzerland and the EU. However it should be taken into account, that the stricter requirements will affect also the domestic market. With the implementation of the new GDP Guidelines the Swiss Federal Office for Health (BAG) decided to perform a survey on the involved stakeholders about the possible effects of a complete acceptance in Switzerland. A first evaluation of the survey showed that, within an adequate time limit, the new Guidelines should be implemented in Switzerland. By the end of June 2015 the Swiss law (AMBV = ordinance for Authorizations within the scope of Medicinal Products) will be revised in order to guarantee the equivalence of the Swiss and European law.

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Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use

The long-awaited guideline GDP for APIs has been published as final versions in the official journal of the European Union.
The guideline is considerably more detailed and contain more stringent requirements than the draft. For instance, the requirements with regard to the quality assurance system of distributors for APIs are much more detailed and demand the tracking and documentation of deviations and a CAPA system.
The guidelines on GDP for APIs provide stand-alone guidance on Good Distribution Practice (GDP) for importers and distributors of active substances for medicinal products for human use. They complement the rules on distribution set out in the guidelines of EudraLex Volume 4, Part II.
Distributors of active substances for medicinal products for human use should follow these guidelines as of 21 September 2015.

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