Brazil proposed Resolution – RDC N° 217, February 20th, 2018. Certification of Good Manufacturing Practices and Certification of Good Distribution and/or Warehousing Practices

Brazilian Health Regulatory Agency (Anvisa) proposed Resolution - RDC N° 39, 14 August 2013, which provides for administrative procedures to grant Certification of Good Manufacturing Practices and Certification of Good Distribution and / or Warehousing Practices.

Art. 1° The article 4 of the Resolution - RDC N° 39, 14 August 2013, which provides for administrative procedures to grant Certification of Good Manufacturing Practices and Certification of Good Distribution and/or Warehousing Practices, becomes effective with the following wording:

"Art. 4 …

Paragraph 1. In order to subsidize the granting of the certification referred to in the caput of this article, Anvisa may use confidential information on inspections received under Agreements or Accords with health authorities of other countries.

Paragraph 2. The granting of the certification referred to in the caput of this article may occur upon presentation of a valid audit report issued by a third auditor recognized by Anvisa, according to specific regulations, and applicable to companies located in the national territory, Mercosur and other countries." (NR)

Art. 2. Paragraph 3 of art. 5 of the Resolution - RDC N° 39, of 2013, shall become effective with the following wording:

"Art. 5 …

Paragraph 3. Anvisa may establish exceptions to the provisions of the caput of this article, which aim to favor the efficiency and optimization of resources related to international inspections, according to previously defined criteria." (NR)

Art. 3. This Resolution revokes the Resolution - RDC N° 179, 27 September 2017.

Art. 4. This Resolution comes into force on the date of its publication.

Products covered: Good Distribution and/or Warehousing Practices

HS code: 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97

Proposed date of adoption: NA

Proposed date of entry into force: NA

Final date for comments: NA

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.