LifeSciences in Brazil n o 123

Transcription

1 LifeSciences in Brazil n o 123 ABOUT THIS NEWSLETTER August Life Sciences in Brazil is a newsletter with information on recent legislation in the areas of Agriculture, Health Care, Innovation, Biotechnology and Biodiversity. The publication is prepared monthly, in Portuguese and in English, by the Life Sciences group of Pinheiro Neto Advogados, under coordination of Angela Fan Chi Kung (akung@pn.com.br) e Camila Martino Parise (cparise@pn.com.br). This newsletter is meant for general informational purposes only and should not be relied upon as legal advice on any specific deal or matter. For more information, please contact our lawyers, or visit our website at To include a recipient in our mailing list, please send names and adresses to pna@pn.com.br. QUICK ACCESS In order to quickly access any section in this newsletter, click on the title below. Highlights Pharmaceuticals and pharmaceutical inputs Animal, plant, agricultural and cattle breeding products Health care professionals SUS Miscellaneous Public consultations (CP) Glossary

2 August HIGHLIGHTS Transfer of ownership of registration of products subject to health control RESOLUTION RDC ANVISA No. 102 OF AUGUST 24, Deals with procedures for transferring the ownership of registration of products subject to health control, overall transfer of responsibility for clinical trial and update of registration data relating to the operation and certification of companies, as a result of corporate and business transactions. PHARMACEUTICALS AND PHARMACEUTICAL INPUTS Monitoring of substances subject to special control RESOLUTION RDC ANVISA No. 96 OF JULY 29, (published on August 01, ) Provides for the monitoring of substances subject to special control and of pharmaceuticals containing them, in pharmaceutical equivalence centers and bioavailability/ bioequivalence centers, and makes other provisions. Registration of specific pharmaceuticals RESOLUTION RDC ANVISA No. 97 OF AUGUST 01, Changes Resolution RDC No. 24 of June 14, 2011 (Deals with registration of specific pharmaceuticals). Classification of drugs as drugs exempted from prescription RESOLUTION RDC ANVISA No. 98 OF AUGUST 01, Provides for criteria and procedures for classifying drugs as drugs exempted from prescription and for reclassifying drugs as prescription drugs. Standardized inserts of specific drugs NORMATIVE RULING ANVISA No. 9 OF AUGUST 01, Provides for standardized inserts of specific drugs

3 August Changes in the deadline of RDC No. 73 RESOLUTION RDC ANVISA No. 100 OF AUGUST 04, Extends the deadline of RDC No. 73 of April 07, (Provides for post-registration changes, cancellation of registration of drugs with synthetic and semi-synthetic active ingredients, and makes other provisions). Prohibition to carry out bidding procedures for purchasing drugs, which establish grouping of different products in single categories RESOLUTION SS No. 75 OF AUGUST 26, Deals with the prohibition to carry out bidding procedures for purchasing drugs, which establish grouping of different products in single categories, and makes other provisions. ANIMAL, PLANT, AGRICULTURAL AND CATTLE BREEDING PRODUCTS Changes in Ordinance No. 711/95 ORDINANCE MAPA No. 155 OF AUGUST 17, Changes the Annex to Ordinance No. 711 of November 01, 1995 (Approves the Technical Rules on premises and equipment for slaughter and industrialization of swine production). Animal testing in Brazil NORMATIVE RESOLUTION MCTI No. 31 OF AUGUST 18, Recognizes alternative methods to animal testing in Brazil. Technical Regulation on peanuts with and without shells NORMATIVE RULING MAPA No. 32 OF AUGUST 24, Establishes Technical Regulation on peanuts with and without shells, for human consumption, defining its official classification standard, quality and identity requirements, sampling, form of presentation, marking and labeling, in the aspects relating to the classification of the product

4 August HEALTH CARE PROFESSIONALS Duties of pharmacists in the logistics, transportation and packaging of biological material RESOLUTION CFF No. 626 OF AUGUST 18, Provides for the duties of pharmacists in the logistics, transportation and packaging of biological material in their different forms and shapes. Pharmaceutical Care Manual ORDINANCE SMS No OF Provides for the Pharmaceutical Care Manual, a basic material to be mandatorily used by pharmacists and pharmacy technicians, and the other professionals involved with pharmacy service, at any management level of the Municipal Health Office. SUS List of Procedures, Drugs, Ortheses and Prostheses and Materials of SUS - Exclusion ORDINANCE SAS No. 961 OF AUGUST 11, Excludes Procedures involving the Pharmaceutical Care Specialized Component from the List of Procedures, Drugs, Ortheses and Prostheses and Materials of SUS. MISCELLANEOUS Changes in Supplementary Law 1,176/2012 SÃO PAULO STATE SUPPLEMENTARY BILL No. 34 OF Changes Supplementary Law 1,176/2012, which provides for the performance of medical and dental activities on a stand-by basis, and makes other provisions

5 August PUBLIC CONSULTATIONS (CP) Before a regulation comes into force, MS, ANVISA or MAPA publishes the proposed regulation for Public Consultation. Comments and suggestions can be submitted by any interested party within a certain period of time as from the publication date of the Public Consultation in the Official Gazette of the Federal Executive. During such period, the Public Consultations are available at or the ANVISA and MAPA websites, respectively. A regulation only comes into force after it is published as a Resolution, Normative Ruling, Ordinance or the like. Rule / Public Consultation (CP) Subject Publication Date Term ANVISA CP No. 236 of July 29, of comments and suggestions on the text of the proposal for amendment to Resolution - RDC No. 01/2008 and to chapter XIX of Resolution RDC No. 81/2008, as regards the procedures for importing and exporting goods and products for scientific or technological research and for researches involving human subjects. August 01, 30 days ANVISA CP No. 237 of July 29, of comments and suggestions relating to the proposed Resolution that adds the culture of coffee, under the foliar application mode, with Maximum Residue Level (MLR) of 0.1 mg/kg and Safety Period of 60 days, to the compendium of the active ingredient E29 - ETHIPROLE. August 01, 30 days - 5 -

6 August Rule / Public Consultation (CP) Subject Publication Date Term ANVISA CP No. 238 of July 29, of comments and suggestions relating to the proposed Resolution that adds the cultures of cotton, sunflower and corn, under the foliar post-emergency application mode, with MRL of 0.01 mg/kg and Safety Period "Not determined due to the application mode and the culture of soybean, under the foliar post-emergency application mode, with MRL of 0.2 mg/kg and Safety Period "Not determined due to the application mode", to the compendium of the active ingredient o D21 - DIQUAT. August 01, 30 days ANVISA CP No. 239 of August 01, of comments and suggestions on the text of the Compendiums of Pharmaceuticals (ESP). August 03, 60 days ANVISA CP No. 240 of August 01, of comments and suggestions on the text of the Active Pharmaceutical Inputs (IFAs). August 03, 60 days ANVISA CP No. 241 of August 08, of comments and suggestions on the text of the Compendiums of herbal drugs and by-products of the Brazilian Pharmacopoeia. August 08, 90 days - 6 -

7 August Rule / Public Consultation (CP) Subject Publication Date Term 18 of August 11, Incorporation in SUS regarding the proposal for preparation of Clinical Protocol and Therapeutic Guidelines for Immunosuppression in Liver Transplant in Adults, as presented by SCTIE/MS. 19 of August 11, Incorporation in SUS regarding the proposal for updated of the Clinical Protocol and Therapeutic Guidelines for Anemia in Chronic Kidney Disease - epoetin alfa, as presented by SCTIE/MS. 20 of August 11, Incorporation in SUS regarding the proposal for update of the Clinical Protocol and Therapeutic Guidelines for Anemia in Chronic Kidney Disease Iron Supplementation, as presented by SCTIE/MS

8 August Rule / Public Consultation (CP) Subject Publication Date Term 21 of August 11, Incorporation in SUS regarding the proposal for update of the Clinical Protocol and Therapeutic Guidelines for Polymyositis and Dermatomyositis, as presented by SCTIE/MS. 22 of August 11, Incorporation in SUS regarding the proposal for update of the Clinical Protocol and Therapeutic Guidelines for Sickle Cell Disease, as presented by SCTIE/MS

9 August GLOSSARY ANVISA National Public Health Agency CFF Federal Council of Pharmacy MAPA Ministry of Agriculture, Cattle Breeding and Supply MCTI Ministry of Science, Technology and Innovation MS Ministry of Health SAS Health Care Office SMS Municipal Health Office SS Health Office SCTIE Office of Science, Technology and Strategic Inputs This issue was compiled by the LifeSciences team of Pinheiro Neto Advogados Angela Fan Chi Kung Camila Martino Parise br), Nicole Recchi Aun Lydia Mauler Lobo Guilherme Gieron Fonseca and Júlia de Castro Kesselring - 9 -