Information for Marketing Authorisation Holders regarding the possibility to request issuance of a provisional measure by the Ministry of Health of the Czech Republic according to the provision 11 (r) Act no. 378/2007 Coll., Act on Pharmaceuticals

In accordance with the provision 11 (r) of the Act on Pharmaceuticals the Ministry of Health of the Czech Republic may in the situation when a verification of safety features appearing on the packaging of the medicinal product is not possible within Article 10 of the Regulation on safety features1 exceptionally temporarily allow distribution and dispensing of such medicinal product by the decision issued at the request of the marketing authorisation holder (“request“) due to the fact that this medicinal product does not comply with the requirements of this Regulation after completion of the production of the medicinal product.