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

Airpharm ISO certification renewal

Esteemed customers,

We are proud to inform you that, following the Bureau Veritas Audit of last May 22nd, 2015, our company obtained the renewal of the ISO 9001 certification.
By logging in into our “Download documents” area you can obtain a copy of the new certificate.

ISO 9001 Quality Management Systems Revision

ISO 9001, the world's leading quality management standard, is under revision, with an updated version (ISO 9001:2015) due by the end of 2015. The International Organisation for Standardization (ISO) has planned this way to give a uniform structure to all management standards. Therefore, the chapters of all norms for Management Systems will be organised with the same chapters, and terms and meanings will be adapted in order to standardize the language used. This will bring to a simplification of the integration of all the management systems in an organisation. The new structure has no influence on the description of the quality management system, but the new requirements are stronger process-oriented and more emphasis is given to a risk based approach.

Organisations already ISO 9001:2008 certified are granted a three-year transition period after the revision has been published to migrate their quality management system to the new edition of the standard.

For more information: Click Here

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.

Source: Click Here

AIRPHARM SA © All Rights Reserved.