Controlled Medicines

Technical Background

Technical Rules applying to substances and medicines subject to special controls, approved by Administrative Rule SVS/MS 344, of May 12, 1998, are based upon the following technical precepts:

• Special Authorization - License granted by the Health Surveillance Secretariat of the Ministry of Health (SVS/MS), to companies, institutions and other bodies, to enable them to engage in the extraction, production, transformation, manufacturing, fractionating, handling, packaging, distribution, transport, repackaging, import and export of the substances listed in the Annexes to this Technical Regulation, as well as the medicines that contain such substances.
  
  
• Authorization for Export - Document sent by the Health Surveillance Secretariat of the Ministry of Health (SVS/MS) corroborating export of the substances appearing in lists "A1" and "A2" (narcotics),"A3", "B1" and "B2" (psychotropic), "C3" (immunosuppressant) and "D1" (precursor) of this Technical Regulation or of its revised versions, as well as the medicines that contain them. See up to date list of substances subject to special controls.
  
  
• Authorization for Import - Document sent by the Health Surveillance Secretariat of the Ministry of Health (SVS/MS ) corroborating import of the substances appearing in lists "A1" and "A2" (narcotics),"A3", "B1" and "B2" (psychotropic), "C3" (immunosuppressant) and "D1" (precursor) of this Technical Regulation or of its revised versions, as well as the medicines that contain such substances.
  
  
• Special Authorization Certificate - Document sent by the Health Surveillance Secretariat of the Ministry of Health (SVS/MS that corroborates the granting of Special Authorization.
  
  
• Certificate of No Objection. Document sent by the competent organ of the Brazilian Ministry of Health , certifying that the substances or medicines being imported or exported are not subject to special controls in Brazil.
  
  
• IDC - International Diseases Classification
  
  
• Annual Import Quota - refers to the quantity of the substance listed at "A1" and "A2" (narcotics), "A3", B1" and "B2" (psychotropic), "C3" (immunosuppressant) and "D1" (precursor) of this Technical Regulation or of its revised versions, that a company is authorized to import in the first quarter of the year following granting of this quota.
  
  
• Supplementary Import Quota - refers to the quantity of the substance listed at "A1" and "A2" (narcotics), "A3", B1" and "B2" (psychotropic), "C3" (immunosuppressant) and "D1" (precursor) of this Technical Regulation or of its revised versions, that a company is authorized to import in addition to the annual quota, additional quantities to meet particular demands by the health services, or for export purposes.
  
  
• Total Annual Import Quota - Sum of the Annual and Supplementary Quotas authorized for each company, for the current year.
  
  
• DCB - Brazilian Common Terminology
  
  
• INN - International Nonproprietary Names
  
  
• Drug - Substance or raw material used for medical or health
  purposes.
  
  
• Narcotic - Substance that can cause physical or psychic dependence described as such in the lists approved by the Single Convention on Narcotics, reproduced in the Annexes of this Technical Regulation.
  
  
• Operating License - A permit granted by the competent health body in the States, Municipalities and the Federal District, which authorizes the operations of an establishment linked to the company which carries out any of the activities referred to in Article 2 of Administrative Rule SVS/MS 344/98.
  
  
• Specific Registration Log - A ledger in which are noted down, in chronological order, the stocks, incoming items (acquired or produced), outgoing items (for sale, processing, use) and mislaid medical drugs subject to special controls.
  
  
• General Prescriptions Log - A ledger in which all the master formulations prepared in pharmacies are noted.
  
  
• Medicine - A pharmaceutical product, obtained or produced by technical means, with a prophylactic, healing, palliative or diagnostic function.
  
  Notification of Prescription - A standard document for notifying medicines which have been prescribed : (a) narcotics (yellow) (b) psychotropics (blue) and (c) retinoids for systemic use and immunosuppressants (white). The Notification regarding the first two groups (a) and (b) must be signed by a professional person duly registered by the Regional Medical Council, by the Regional Council of Veterinary Medicine or by the Regional Dentistry Council. As for the third group (c), this must be signed exclusively by a professional duly registered by the Regional Medical Council.
  
  
• Precursor - Substances used for the processing of narcotics or psychotropics and appearing in the lists approved by the Convention Against Illicit Trafficking of Narcotics and Psychotropic Substances, reproduced in the Annexes to this Technical Regulation.
  
  
• Master preparation - Medicine prepared in a pharmacy on the basis of a commonly prescribed master formula.
  
  
• Psychotropic - A substance that can cause physical or psychic dependence described as such in the lists approved by the Single Convention on Narcotics, reproduced in the Annexes of this Technical Regulation.
  
  
• Prescription - A written prescription for medicine, whether of a master formula or a manufactured product, containing directions on its use by patients and issued by a legally authorized professional.
  
  
• Banned substance - A substance whose use is prohibited in Brazil.