Brazil - Proposed Resolution nº 343 for medicinal products

Brazilian Health Regulatory Agency (Anvisa) provides Resolution for good distribution and storage practices as well as good practices for the transport of medicinal products. It applies to companies that carry out the activities of distribution, storage or transport of medicines. This resolution does not apply to the distribution storage and transportation activities of raw materials, bulk drugs, labels, packaging or medicinal gases.

All parties involved in the production, storage, distribution and transportation should be responsible for the quality and safety of the medicines. Shared responsibility covers recall actions, whether motivated by the health authority, the registrant or the distributor. Manufacturers must provide medicines only to companies authorized and licensed by the competent sanitary authority for distribution activities or delivery of medicines to patients. The companies involved in the distribution activity should only obtain supplies of medicines purchased directly from the companies that hold the registration and should only provide to companies authorized and licensed to delivery to patients.

This resolution also establishes provisions regarding the organization and administration; staff; quality management system; storage areas installations; storage; expedition and receipt; transport and in-transit storage; vehicles and equipments; containers; documentation; complaints; withdraw; returns; adulterated, falsified, robbed or stolen medicines; subcontracted activities; self-inspections; qualifications and validations and thermolabile medicines.

This resolution revokes the Ministerial Order nº 802 of 8 October 1198 and the Resolution – RDC nº 320 of 22 November 2002, and the article 3º of the Ministerial Order nº 2.814/GM/MS of 29 May 1998.

This resolution comes into force on the date of its publication.

Products covered : medicinal products

Proposed date of adoption : To be determined after the end of the consultation period

Proposed date of entry into force : This resolution comes into force on the date of its publication.

Final date for comments : 10 July 2017

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.