After four years of study and intensive negotiations, the Joint Board of Anvisa accepted the proposal from Sindusfarma, publishing this Wednesday (5/8) normative instruction nº 2, 8/4/2015, authorising the sharing of facilities and equipment for the production of medicines, cosmetics, health products and food supplements.
The exhausting work, coordinated by Jair Calixto, Manager of good practice and Pharmaceutical Audits of pharmaceutical industry Union in the State of São Paulo (Sindusfarma), together with associated enterprises, demonstrated the feasibility of production of certain products in the same pharmaceutical facilities.
Initially, in March 2011, the Sindusfarma discussed with Anvisa the possibility of manufacture of veterinary medicinal products alongside medicines for human use.
The result of this action was the publication by Anvisa, in 4/23/2012, the technical note that set out the following: "is technically acceptable, from the point of health risk visa, the production of veterinary products in the same premises licensed for the manufacture of medicinal products for human use, in cases where the veterinary products contain inputs approved for human use".
Over the course of 2012, the proposal advanced to the production shared between medicines, cosmetics, food supplements and health products. All of the studies, prepared with subsidies from associated companies, were gathered in documents sent to the Anvisa in June, September and November of that year.
Public Consultations
The recommendations of the Sindusfarma resulted, in July 2013, at the opening of the public consultation no. 26, July 12, 2013, which was the resolution which provides for amendment to article 252 of the RDC No. 17/2010.
Later, in March 2014, was open to public consultation no. 8, March 10, 2014, available on the health products, toiletries, cosmetics and/or food whose manufacture in plant and equipment can be shared with medicines for human use, according to the requirements of the health legislation in force, regardless of prior approval by Anvisa.
Legal opinion
In June 2014, before some questions viz. by the General Management (GGIMP) from Anvisa, the Sindusfarma presented legal opinion, drawn up with the assistance of the legal counsel of the entity, in which served the proposals contemplated by paragraph 26/2013 CP and CP No. 08/2014.
In June 2015, the Sindusfarma reaffirmed the relevance of the initiative, forwarding to Anvisa the matching CT No. 165/2015, which explained the importance and the benefits that it would bring to the pharmaceutical industry, creating possibilities to rationalize their productive activities and develop new business opportunities. Also pondering that such regulation would reduce regulatory differences globally, demonstrating maturity and advancement by the Anvisa and equating it to the main international agencies.
Finally, the effort of the Sindusfarma full success was crowned with the adoption of the measure at a meeting of the Joint Board of Anvisa in 7/16/2015 and the publication of IN this Wednesday (5/8), in the Official Gazette.
"The Sindusfarma thanks all the professionals in the pharmaceutical industries associated with that assisted in the preparation of the studies that were sent to the Anvisa," says Jair.
Read below the full text of the resolution:
NORMATIVE INSTRUCTION nº 2, AUGUST 4 2015
GIVE 8/5/2015
Rules on health products, toiletries, cosmetics and/or food whose manufacture in plant and equipment can be shared with medicines for human use, according to the requirements of the health legislation in force, regardless of prior approval by Anvisa.
The Joint Board of the national health surveillance Agency, the use of assignments that provide items III and IV, art. 15 of law No. 9,782, January 26, 1999, item VI, and §§ 1 and 3 of art. 58 of the internal regulations approved in accordance with Annex I of the Collegiate Board week ago-RDC No. 29, July 21, 2015, published in D. U. of July 23, 2015, taking into account the provisions of subparagraphs III of art. 2, 3 and 4, art. 7 of law nº 9,782, 1999, and the program of improvement of the Agency's regulatory Process established by Ordinance No. 422, April 16, 2008, in ordinary meeting No. 13/2015, held in July 16, 2015,
Adopts the following Normative and I, ceo determine your publication:
Art. 1 The health products, toiletries, cosmetics and/or food whose manufacture shared is preliminarily admitted as possible by Anvisa in productive areas and equipment intended for the manufacture of medicines are cited below:
I-intimate lubricants, adhesives for topical use, dental bleaching, dental bleaching, intra-canais solutions for cleaning and disinfection of contact lenses, with regard to health products;
II-10 to 40 volume hydrogen peroxide, jammers/sunscreens, skin bleaching, anti-dandruff conditioners/loss, anticárie/antiplaca/antitártaro toothpastes/for sensitive teeth bleaching, mouth rinses anticárie/antiplaca/antitártaro/bleaching, rinses anti-dandruff hair/anti, "peeling" chemical exfoliants, acneica skin care products, lip balms with fotoproteção, antiseptic soaps, talc/post antiseptics, tonics/hair lotion, anti-dandruff shampoos/conditioners anti-dandruff shampoos, anti/anti with respect to Cosmetics and toiletries; and
III-vitamin supplements and/or minerals, foods with claims property and/or health functional, bioactive compounds and probiotics isolated with allegation of functional properties and/or health.
Sole paragraph. The authorisation granted in the chapeau does not exclude the need for full compliance with the sanitary legislation applicable to each of these categories, in particular the provisions of the art. 252, the resolution RDC No. 17, April 16, 2010.
Art. 2 the manufacture of products not listed in the shared items of art. 1st depends on Anvisa's prior authorization being requested through the subject code 70275-authorization for the manufacture of products for health, hygiene Products, cosmetics and/or food.
Art. 3 the request indicated in art. 2 must be accompanied by the following documents:
I-list of medicines for human use currently produced at the facility to be used for sharing;
II. Description of the qualitative and quantitative composition of the product for health, hygiene, cosmetic product or food if you want to share;
III-demonstration that the specifications adopted by the company for the raw materials of the product that you want to share with the medicines for human use are of equal or superior quality to those used to these;
IV. discrimination of manufacturing flow that will be shared with medicines for human use, citing in detail, storage of raw materials to the shipment of finished products, the areas and shared equipment;
V-floorplans of the manufacturing areas in which sharing occurs demonstrating the flow of people, material flow, pressure differentials and classification on the number of particles when applicable as standard adopted by resolution RDC No. 17, April 16, 2010; and
VI-analysis of risk identification, analysis, and contemplating the risk assessment, risk reduction mitigáveis and the decision regarding the acceptability of the remaining risks.
Art. 4 the documentation listed in the preceding article may be complemented by a sanitary inspection if necessary to the conclusion about the sharing request.
Art. 5 the authorization granted to the products listed in items of art. 1st do not absolve companies at any time to present the documents listed in art. third, when requested by the supervisory bodies.
Art. 6 the inclusion of health products, toiletries, cosmetics and/or food in production lines of medicines must meet the compatibility of routes of administration, getting those products may not include categories with routes of Administration other than those used for medicinal products manufactured on target production line of inclusion.
(1) Except as provided in the heading itself, the products whose inputs have had their safety for use in medicines and approved.
(2) Except as provided in the heading itself, the products that share with medicines manufacturing areas that do not involve the direct formulation of drugs such as weighing, sampling, storage and secondary packaging.
Art. 7 the omissive cases in this Normative shall be examined and decided by Anvisa, can be requested for larger companies share information.
Art. 8 This normative instruction shall enter into force on the date of its publication.
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