Brazil proposed Procedures related to the revalidation of product registration and provides other measures

Brazilian Health Regulatory Agency (Anvisa) proposed Resolution changes the Resolution - RDC No. 250 of 20 October 2004, which provides for procedures related to the revalidation of product registration and provides other measures.

The caput of art. 1 and of art. 4 of the Resolution - RDC No. 250, dated 20 October 2004, shall become effective with the following wording:

"Article 1. The revalidation of the registration must be requested in advance of a maximum of twelve months and a minimum of six months of the date of maturity of the registration, being considered automatically revalidated, regardless of the decision, if it has not been rendered until the day of termination of that."

"Art. 4 In the counting of the term to request the revalidation of the record, the final day of validity will be considered as the day of the beginning to count down the maximum advance of twelve months and minimum of six months of the day of registration, under the terms of the previous article."

It is revoked the paragraph 3 of art. 2 of the Resolution - RDC No. 250, 2004.

Products covered: All Products

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.