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Starting from 2 July, all imported active ingredients, produced in a non-EU country, must be accompanied by written confirmation that guarantees compliance with GMP standards (good manufacturing practices). The document must be drawn up by the competent authority of the exporting country which confirms that the substance complies with the Gmps and that the controls of the production plant comply with those carried out in the European Union. These requirements are one of the innovations introduced in the European directive on falsified medicines, which came into force last January, to constitute a legal substrate for the concept of international cooperation on active substances which presupposes the sharing of responsibilities with local regulatory authorities. The written confirmation must ensure that: the Gmp standards applicable to the plant are at least equivalent to those in force in the EU; the production plant is subject to regular and strict controls, Gmp confirmation and inspections; information relating to any episodes of non-compliance will be transmitted by the exporting country to the importing European country without any delay. To simplify the guarantee document, it will not be required of those countries that have a regulatory approach that can be superimposed on the European one: upon submitting a request to the Union authorities and having received an affirmative answer, the exporting country will be included in a list of "equivalent countries". Currently on this list are: Australia, Japan, Switzerland and the United States, Brazil is under evaluation, Israel and Singapore have applied.

8 July 2013 – Pharmacist33

Related news: https://www.fedaiisf.it/Start/HDefault.aspx?Newsid=8036






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