Argentina - Drug Information Association

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-Annex two provides application forms, guidelines and documents' requirements. -Annex three includes the guidelines and application forms for the submission of the documents attached. The Secretary of Health shall not demand applicants registered in the Formalities and Services Federal Register of additional procedures or application forms and shall only apply them as set forth in the Formalities and Services Federal Register, except as provided in article 69-Q of the Federal Law of Administrative Procedure. Applicants shall apply in writing including: name, corporate name, agent, address, holder name, reasons of request, body name and place and date of issue. All the documents submitted by applicants shall be the original copy. COFEPRIS shall issue a decision within 3 months. Moreover, anything to the contrary provided by this agreement or if applications do not meeting the requirements set forth in article 17 (A) of the federal Law of Administrative Procedures, applicants concerned shall be notified a non-extendible term to rectify any mistake in writing once. The deadline shall not be earlier than 5 working days and not exceed procedure half-term. Comment: This agreement repeals: -Agreement Adding the Registration Procedures for Accredited Individuals to the Agreement Informing About the Procedures and Services, Together with the Application Forms, which are Applied by the Ministry of Health (MOH), Through the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), 01-Jun- 2010 (109167). - Agreement Informing About the Procedures and Services, Together with the Application Forms, that are Applied by the Ministry of Health (MOH), Through the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), 19-Jun-2009 - Part 1/4 (92652). - Agreement Informing About the Procedures and Services, Together with the Application Forms, that are Applied by the Ministry of Health (MOH), Through the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), 19-Jun-2009 - Part 2/4 (92654). - Agreement Informing About the Procedures and Services, Together with the Application Forms, that are Applied by the Ministry of Health (MOH), Through the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), 19-Jun-2009 – Part 3/4 (92660). - Agreement Informing About the Procedures and Services, Together with the Application Forms, that are Applied by the Ministry of Health (MOH), Through the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), 19-Jun-2009 - Part 4/4 (92661). This agreement amends annex III of Agreement that establishes the General Rules of the Secretariat of Health through the COFEPRIS, for the Conduct of Procedures using Electronic Media, 08-Dec-2005 (54555). Document date: 21-Dec-2010 Type of text: Agreement Regulatory version: Amendment Language: Spanish Mexico - Agreement Informing About the Procedures & Services and the Application Forms, Applied by the Ministry of Health (MOH), Through the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), 21-Dec-2010 - Part 4/4 This agreement provides the procedures the Ministry of Health is in charge of, included in article 69 (M) of the Formalities and Services Federal Register. -Annex one puts forward the cases requiring operation notice submission or sanitary licence. -Annex two provides application forms, guidelines and documents' requirements. -Annex three includes the guidelines and application forms for the submission of the documents attached. The Secretary of Health shall not demand applicants registered in the Formalities and Services Federal Register of additional procedures or application forms and shall only apply them as set forth in the Formalities and Services Federal Register, except as provided in article 69-Q of the Federal Law of Administrative Procedure. Applicants shall apply in writing including: name, corporate name, agent, address, holder name, reasons of request, body name and place and date of issue. All the documents submitted by applicants shall be the original copy. COFEPRIS shall issue a decision within 3 months. Moreover, anything to the contrary provided by this agreement or if applications do not meeting the requirements set forth in article 17 (A) of the federal Law of Administrative Procedures, applicants concerned shall be notified a non-extendible term to rectify any mistake in writing once. The deadline shall not be earlier than 5 working days and not exceed procedure half-term. Comment: This agreement repeals: -Agreement Adding the Registration Procedures for Accredited Individuals to the Agreement Informing About the Procedures and Services, Together with the Application Forms, which are Applied by the Ministry of Health (MOH), Through the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), 01-Jun- 2010 (109167). - Agreement Informing About the Procedures and Services, Together with the Application Forms, that are Applied by the Ministry of Health (MOH), Through the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), 19-Jun-2009 - Part 1/4 (92652). - Agreement Informing About the Procedures and Services, Together with the Application Forms, that are Applied by the Ministry of Health (MOH), Through the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), 19-Jun-2009 - Part 2/4 (92654). - Agreement Informing About the Procedures and Services, Together with the Application Forms, that are Applied by the Ministry of Health (MOH), Through the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), 19-Jun-2009 – Part 3/4 (92660). - Agreement Informing About the Procedures and Services, Together with the Application Forms, that are Applied by the Ministry of Health (MOH), Through the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), 19-Jun-2009 - Part 4/4 (92661). This agreement amends annex III of Agreement that establishes the General Rules of the Secretariat of Health through the COFEPRIS, for the Conduct of Procedures using Electronic Media, 08-Dec-2005 (54555). Document date: 21-Dec-2010 Type of text: Agreement Regulatory version: Amendment Language: Spanish
Mexico - Announcement to Adverse <strong>Drug</strong> Reaction Reporters to the National Centre of Pharmacovigilance, 25-Jan-2011 COFEPRIS informs from the 26th of January 2011, ADR reports shall include at least the following information: - Patients’ details: initials, age, date of birth (DD/MM/YYYY). - Suspect medicinal product: Brand name, International Non-proprietary Name (INN), dosage, administration start and end dates (DD/MM/YYYY). - Adverse drug reactions’ data: symptoms and date when they began (DD/MM/YYYY). - ADR Reporters’ details: Name. In the event of omitting this information, ADR reports shall be dismissed and sent back to reporters to include this information. Document date: 25-Jan-2011 Type of text: Press release Regulatory version: None Language: Spanish Mexico - Press release 005/11: COFEPRIS Called Off 613 Unlawful Advertisements in 2010, 20-Jan-2011 COFEPRIS called off 613 advertisements in 2010 promoting products with therapeutic and preventive effects to relieve, treat or prevent diseases or disorders without scientific foundation. These substances were promoted as “miracle products” to rejuvenate, reduce weight, treat liver and cure or prevent cancer. The contraindications were not provided in the packaging and the national centre of pharmacovigilance destroyed 247,638 products since they were found to be detrimental to health. Document date: 20-Jan-2011 Type of text: Press release Regulatory version: None Language: Spanish Peru Peru - Deadlines for the Submission of Balance Sheets of Consumption and Import and Export Forecasts of Narcotics, Precursors and Psychotropics, 2011 This document provides deadlines for manufacturing plants and drugstores to submit: - quarterly balance sheets to report on the consumption and balance of not imported narcotics, precursors and psychotropics for 2011 and 2012. - application forms to report on consumption and balance of imported narcotics, precursors and psychotropics for 2011. - application forms to report on import and export forecasts for 2012. Comment: This document should be read together with Form: Application to Report on Import Forecasts of Narcotics' and Psychotropics' Active Ingredients and Medicinal Products Included in Decree 023-2001-SA, 2010 (112961), Form: Application to Report on Export Forecasts of Narcotics' and Psychotropics' Active Ingredients and Medicinal Products Included in Decree 023-2001-SA, 2010 (112963), Form: Application for the Annual Balance and Consumption of Imported Narcotics' and Psychotropics' Active Ingredients and Medicinal Products, Included in Decree 023-2001-SA, 2010 (112991) and Decree 023-2001-SA: Adopts Regulation on Psychotropics, Narcotics and Other Substances Subject to Sanitary Control, 21-Jul-2001 (111356). Document date: 2011 Type of text: List Regulatory version: None Language: Spanish Poland Poland - Decree 08.184.1143 of 01-Oct-2008: Good Manufacturing Practice (as last Amended by Decree 11.19.99 of 23-Dec-2010) This decrees defines: 1) general requirements of good manufacturing practice; 2) detailed requirements of good manufacturing practice, included in the annex to this decree. Compliance with these requirements is necessary to obtain manufacturing or import licence. Paragraph 2 to this decree includes a glossary. By the "Decree 08.184.1143 of 01-Oct- 2008: Good Manufacturing Practice" (86242) the decree 06.194.1436 of 02-Oct-2006: Ministry of Health - Requirements for Good Manufacturing Practice" (62075) is outdated. The decree 08.184.1143 of 01-Oct-2008: Good Manufacturing Practice (86242) has been amended by the decree 11.19.99 of 23-Dec-2010 (119239) as follow: - In the § 2, points: 5, 11, 13, 14, 15, 40, 73, 80, 114 and 115 are changed, whereas following points are added: 8a, 56a, 72a, 79a, 84a. - Part II: Basic requirements for active substances used as starting materials is replaced by the annex 1. - Annex 6: Manufacturing of medicial gases is replaced by the annex 2. - Annex 13: Manufacturing of investigational medicinal products is replaced by the annex 3 of this new Decree 11.19.99 of 23-Dec-2010. Comment: This document has been amended by IDRAC according to the Decree 11.19.99 of 23-Dec-2010 listed in the Regulatory History and Timetable available at the top of the document; the modifications brought by the last amendment are highlighted in blue. Document date: 01-Oct-2008 Type of text: Decrees (Rozporządzenia) Regulatory version: Amended
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Argentina - Drug Information Association

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