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-CMC 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 (10), Directive 2001/82/EC of the European Parliament and of the Council (11) or Regulation (EC) No 726/2004 of the European Parliament and of the Council (12); b. [...] 13 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. [...] In some cases, the seizure was either reported by the laboratory that analysed the sample, without specifying whether the seizure was made by police or customs, the identity of the reporting authority was either not specified by the reporting country or not clear from the reports submitted to the EMCDDA. [...] The presence of iso-3-CMC in these seizures could be as a result of dimerisation due to the reaction of the alpha-haloketone and the amine.
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- 35
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- Portugal
