Brazil proposed resolution for activities involving the substance lenalidomide and the medicine Brazilian Health Regulatory Agency (Anvisa) proposed resolution provides for activities involving the substance lenalidomide and the medicine containing it. Substances listed in Schedule C3 listed in Annex I of Portaria SVS 344/98 and its updates, with the exception of thalidomide, shall comply with the requirements set forth in this Resolution after evaluation and express determination of Anvisa. The market authorization holder of the lenalidomide medicine shall implement a supply, marketing, distribution and dispensation program to comply with the Pregnancy Prevention Plan (PPG) previously approved by Anvisa. The manipulation of the active pharmaceutical ingredient (API) lenalidomide, the medicinal product containing it or of formulas containing lenalidomide in pharmacies is prohibited. In addition to complying with the standards that regulate Good Manufacturing Practices for the production of API and medicines in the national territory, it is mandatory that companies provide individual and collective protection equipment that protects workers from exposure to the product and monitors their use in all stages of production the substance and the manufacture of the lenalidomide medicine. The presence of women on production and manufacturing lines is prohibited in any of the steps leading to product exposure. Distributors of the medicines must be previously qualified by the market authorization holder of the lenalidomide medicine for their regularity of health and technical and safety capability for the distribution of this medicine. Any movement of the lenalidomide substance, as well as the medicine containing it, even when sent for analytical or research purposes, must be carried out by issuing an Invoice or equivalent document. The importation and exportation of the substance lenalidomide or the medicine containing it shall comply with the requirements of Portaria SVS / MS no. 344/98, Portaria nº 6/99, RDC no. 99/2008, RDC 11/2013 or those that replace it. This Resolution also contains informations on teaching and research; registration; prescription; dispensation; bookkeeping and balance sheets; package; free sample; pharmacovigilance; refund; disposal; inspection. Product cover: Pharmaceutical products HS code: 30 Proposed date of adoption: NA Proposed date of entry into force: NA Final date for comments: 30-09-2017 | 
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