13.12.2019
To the attention of interested persons
Practical guide developed by the CMDh for the attention of Marketing Authorisation Holders (MAHs) for medicinal products authorised nationally (also through Mutual Recognition Procedures – MRP/Decentralised Procedure – DCP) in relation to the referral procedure triggered under the provisions of Article 5(3) of Regulation No 726/2004, relating to nitrosamine impurities.
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