cover image: ADVANCED RELEASE

20.500.12592/9wqgvh

ADVANCED RELEASE

22 Dec 2021

Information collection process In accordance with the requirements of Article 5b of the Regulation, on 13 September 2021, the EMCDDA launched a procedure for the collection of additional information on 3-MMC in order to support the production of the initial report. [...] a medicinal product for human use or in a veterinary medicinal product that has obtained a marketing authorisation in accordance with Directive 2001/83/ EC of the European Parliament and of the Council (11), Directive 2001/82/EC of the European Parliament and of the Council (12) or Regulation (EC) No 726/2004 of the European Parliament and of the Council (13); b. [...] 14 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. [...] a medicinal product for human use or in a veterinary medicinal product that has obtained a marketing authorisation in accordance with Directive 2001/83/ EC of the European Parliament and of the Council, Directive 2001/82/EC of the European Parliament and of the Council or Regulation (EC) No 726/2004 of the European Parliament and of the Council; b. [...] The information included in the preparation of this report is public 32 of 48 • France reported that 3-MMC is controlled since 2012; • Germany reported that 3-MMC is controlled as a non-marketable narcotic drug (Annex I) of the German Narcotic Drugs Act, since 2014; • Italy reported that 3-MMC was included in the list of new psychoactive substances in the update of 29 December 2020 of the decree o.
Pages
48
Published in
Portugal

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