The Ministry of Health decided that the ANMAT, within 90 days, establish a record of insect repellent products, replacing the existing mechanism for automatic admission and receive a certificate enabling for commercialization.
By Order 327/2012, signing the Health Minister, Juan Manzur, published today in the Official Gazette, set out the requirements for registration and marketing approval of repellents for human use in the country.
In the grounds states that has called for discussion and development of this standard to the National Drug Institute (INAME) under the National Drug and Tecbología (ANMAT)., Which is responsible for the admission of such products.
Adds that the Commission has unanimously considered that the nature of governing automatic admission to date to allow the marketing of these products is inadequate, both for its toxicity and the risk of inefficiency and consequent exposure to diseases transmitted by insect vectors.
He added that professionals from different Poison Centers in the country have expressed concern about the adverse effects to health due to incorrect selection and use of repellents in humans.
He also says that technically discussed the feasibility of a procedural framework for the evaluation and registration of these products, comparable to that used in other countries or regions such as USA and EU.
The resolution states that are reached by the activities of preparation, portioning, import, storage and sale of insect repellent products for external use in humans and the natural or legal persons involved in such activities. The National Food, Drug and Medical Technology (ANMAT) will be the enforcement authority.
Defined as insect repellent products for external use in humans to those substances, compounds and / or preparations that are applied in order to repel insects and thus avoid stings, discomfort or reactions derived from them and the possible transmission of diseases For insect vectors.
The A.N.M.A.T. shall establish, within a period not exceeding 90 days, a record of insect repellent products for external use in humans to replace the current mechanism of automatic admission to today and receive a certificate qualifying them to market and use for those products whose physical and chemical characteristics ensure their effectiveness, safety, stability and quality during storage, transport and use.
Authorization certificate will be valid for 5 years, subject to such authorization can be reviewed at any time in the light of scientific advances and that can require additional information from the registrant for review.
The A.N.M.A.T. shall establish, within a period not exceeding 90 days, the following specifications: a) technical aptitude, qualification and establishment characteristics, production processes and all other necessary condition for processing companies, bottling and / or importers of products for use repellents human. b) information required for registration of compounds and products, including physical and chemical characteristics, toxicological, clinical presentation, metabolic and toxicological studies and any other information as appropriate to maximize the safe use of the product. c) characteristics of label including at least the percentage composition, expiration date, lot number, indications and limitations of use, reference data of the manufacturer or importer and telephone number of the National Poison Center.
The A.N.M.A.T. guides considered valid for the registration process, the background current authorization and categorization of active ingredients for insect repellents by the Environmental Protection Agency's (USEPA) or the European Union (EU) and requirements for efficacy testing protocols as the "Test Guidelines OPPTS 810.3700 Performance for insect repellents for human skin and outdoor premises" USEPA and the "Guidelines on efficacy testing of mosquito repellents for human WHO / HTM / NTD / WHOPES / 2009.4 ", the World Health Organization and their respective updates.
Not be allowed formulations of insect repellent products for external use in humans containing substances with mutagenic or teratogenic, substances belonging to the categories IA, IB, and II of the list of the International Agency for Research on Cancer United Nations (International Agency for Research of Cancer - IARC), which produce endocrine disruption or are caustic, irritating or sensitizing.
Insect repellents for external use shall not claim on their labels, packaging or advertising any therapeutic activity, specific action for any particular insect, or refer to the prevention of foodborne diseases. The advertising of these products must not mislead as to the risks to humans, or include any mention on their assessment as risk: low-risk product, non-toxic, harmless, environmental, natural, suitable for children, or any other similar legend. Instead, you must be consistently and prominently the phrases "Use repellents safely." "Read the label and product information before use".
By Order 327/2012, signing the Health Minister, Juan Manzur, published today in the Official Gazette, set out the requirements for registration and marketing approval of repellents for human use in the country.
In the grounds states that has called for discussion and development of this standard to the National Drug Institute (INAME) under the National Drug and Tecbología (ANMAT)., Which is responsible for the admission of such products.
Adds that the Commission has unanimously considered that the nature of governing automatic admission to date to allow the marketing of these products is inadequate, both for its toxicity and the risk of inefficiency and consequent exposure to diseases transmitted by insect vectors.
He added that professionals from different Poison Centers in the country have expressed concern about the adverse effects to health due to incorrect selection and use of repellents in humans.
He also says that technically discussed the feasibility of a procedural framework for the evaluation and registration of these products, comparable to that used in other countries or regions such as USA and EU.
The resolution states that are reached by the activities of preparation, portioning, import, storage and sale of insect repellent products for external use in humans and the natural or legal persons involved in such activities. The National Food, Drug and Medical Technology (ANMAT) will be the enforcement authority.
Defined as insect repellent products for external use in humans to those substances, compounds and / or preparations that are applied in order to repel insects and thus avoid stings, discomfort or reactions derived from them and the possible transmission of diseases For insect vectors.
The A.N.M.A.T. shall establish, within a period not exceeding 90 days, a record of insect repellent products for external use in humans to replace the current mechanism of automatic admission to today and receive a certificate qualifying them to market and use for those products whose physical and chemical characteristics ensure their effectiveness, safety, stability and quality during storage, transport and use.
Authorization certificate will be valid for 5 years, subject to such authorization can be reviewed at any time in the light of scientific advances and that can require additional information from the registrant for review.
The A.N.M.A.T. shall establish, within a period not exceeding 90 days, the following specifications: a) technical aptitude, qualification and establishment characteristics, production processes and all other necessary condition for processing companies, bottling and / or importers of products for use repellents human. b) information required for registration of compounds and products, including physical and chemical characteristics, toxicological, clinical presentation, metabolic and toxicological studies and any other information as appropriate to maximize the safe use of the product. c) characteristics of label including at least the percentage composition, expiration date, lot number, indications and limitations of use, reference data of the manufacturer or importer and telephone number of the National Poison Center.
The A.N.M.A.T. guides considered valid for the registration process, the background current authorization and categorization of active ingredients for insect repellents by the Environmental Protection Agency's (USEPA) or the European Union (EU) and requirements for efficacy testing protocols as the "Test Guidelines OPPTS 810.3700 Performance for insect repellents for human skin and outdoor premises" USEPA and the "Guidelines on efficacy testing of mosquito repellents for human WHO / HTM / NTD / WHOPES / 2009.4 ", the World Health Organization and their respective updates.
Not be allowed formulations of insect repellent products for external use in humans containing substances with mutagenic or teratogenic, substances belonging to the categories IA, IB, and II of the list of the International Agency for Research on Cancer United Nations (International Agency for Research of Cancer - IARC), which produce endocrine disruption or are caustic, irritating or sensitizing.
Insect repellents for external use shall not claim on their labels, packaging or advertising any therapeutic activity, specific action for any particular insect, or refer to the prevention of foodborne diseases. The advertising of these products must not mislead as to the risks to humans, or include any mention on their assessment as risk: low-risk product, non-toxic, harmless, environmental, natural, suitable for children, or any other similar legend. Instead, you must be consistently and prominently the phrases "Use repellents safely." "Read the label and product information before use".
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