The Board (Dicol) Anvisa approved, on Tuesday (8/3), a resolution amending the SVS / MS 34/1998. The standard deals with transitional food for infants, babies from zero to twelve months of incomplete age, and young children, those aged from twelve months to three years.
Changing the item 22.214.171.124 of the Ordinance will allow the entry on the market of products ready for consumption, such as soups and purees in frozen form and after filling. Thus, the rule is in line with international standards and meet the movement of companies to settle the frozen food for this age group.
The Dicol also approved resolution establishing criteria for granting and canceling the license of Pharmaceutical Equivalents centers and review of the Collegiate Board Resolution (RDC) 47/2006 to update the list of UV filters allowed for personal hygiene products, cosmetics and perfumes.
During the meeting, the board revoked the DRC 29/2009 on technical proficiency testing to perform residue studies.
The new texts will be published Official Daily of the Union in the coming days.
Already the DRC regarding the outsourcing of production, quality and drug storage control analysis left the deliberative agenda. The director José Carlos Moutinho requested reviews the case.
Initiatives – The update of technical requirements for labeling toiletries, cosmetics and perfumes was approved on common rules. The proposed regulation should be the need to internalize rules adopted in Mercosur. The Rapporteur will be the responsibility of the CEO Jarbas Barbosa.
It was also approved by the board of the regulatory procedures for the receipt of documents by electronic means. The proceedings will be expedited procedure.
Another regulation initiative approved refers to the review of the DRC 31/2010, which discusses the studies of pharmaceutical equivalence and comparative dissolution profile. The proposal is to update the current regulations as a result of the natural evolution of technical and scientific studies. The Rapporteur also took the CEO Jarbas Barbosa.
The four proposals for Public Consultation (CP) on the agenda were approved. The first three dealing with the inclusion of Pharmacopeial Monographs three Radiopharmaceuticals in the edition of the Brazilian Pharmacopeia will have the deadline for contributions is 30 days.
The radiopharmaceuticals are: sodium Medronato (99m Tc), sodium Pentetate (99m Tc) and Sodium Pertechnetate (99m Tc).
Already the CP to review the Instruction No. 6 of 18 November 2011 laying down specific criteria for grouping families health in the use of materials for registration and registration will have a term of 60 days after the publication of the Official Gazette and Portal Anvisa.