WHO Cirtificate pdf

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World Health Organization WHO

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Compiled by-Shamon Ahmad M.Pharma Q.A Chandigarh Group of Colleges Landra MohaliPunjab Indiaemail-shmmongmail.com 25/12/2012 About WHO WHO is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters shaping the health research agenda setting norms and standards articulating evidence-based policy options providing technical support to countries and monitoring and assessing health trends. In the 21st century health is a shared responsibility involving equitable access to essential care and collective defence against transnational threats. Certification International Commission for the Certification of Dracunculiasis Eradication In May 1995 WHO’s Director-General established an International Commission for the Certification of Dracunculiasis Eradication to verify and confirm information from countries claiming the absence of indigenous dracunculiasis transmission. The Commission has met eight times since its establishment in 1995. As of 1 January 2012 the Commission has certified 192 countries and territoriesarea including 180 WHO Member States as free of dracunculiasis transmission. These certified countries were

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endemic at the start of eradicationfailana programme include Benin Burkina Faso Cameroon Central African Republic India Mauritania Pakistan Senegal Togo Uganda and Yemen. Types of Certificates: Types of Certificates WHO-type Certificate Certificate of Pharmaceutical Product WHO 1975 type Certificate of a Pharmaceutical Product WHO 1988 type Certificate of a Pharmaceutical Product WHO 1992 type Statement of Licensing Status WHO 1992 type a Certificate of Pharmaceutical Product WHO 1975 type: a Certificate of Pharmaceutical Product WHO 1975 type The 1975 version of the WHO- type Certificate of a Pharmaceutical Product is a certificate to be issued by a competent authority regulatory authority of the exporting country The certificate combines 1 and 2 below in a single document that the product has been authorized to be placed on the market for use in the country including the number of permit and date of issue or that the product has not been authorized to be placed on the market for use in the country and the reasons why that: a the manufacturing plant in which the product is produced is subject to inspections at suitable intervals and b the manufacturer conforms to GMP requirements as recommended by WHO in respect of products to be sold or distributed within the country of origin or to be exported. b Certificate of a Pharmaceutical Product WHO 1988 type The 1988 format of the Certificate of a Pharmaceutical Product is similar to the 1975 version but in addition the competent authority of the exporting country is required to provide copies of the complete text of all labelling and product information which is authorized in the country of origin. c Certificate of a Pharmaceutical Product WHO 1992 type This is intended for use by the competent authority of an importing country in two situations: a when the product in question is under consideration for a product license that will authorize its importation and sale and b when administrative action is required to renew extend vary or review such a license. The certificate provides information on the following: whether a product is licensed to be placed on the market and if not the reasons why whether the applicant manufactures the dosage forms packages and/or labels a finished dosage form manufactured by an independent company. if the manufacturer of the product has been inspected and the periodicity of inspection if the certificate is provisional pending technical review whether the information submitted by the applicant satisfies the certifying authority on all aspects of the manufacture of the product undertaken by another party states the names of the importing and exporting certifying countries REQUESTING A CERTIFICATE : REQUESTING A CERTIFICATE Three documents can be requested within the scope of the scheme A certificate of a pharmaceutical product A statement of licensing status of pharmaceutical product. Batch certificate of pharmaceutical products. All participating countries are encouraged to adopt these formats to facilitate interpretation of certified information. A list of addresses of competent national regulatory authorities participating in the scheme may be obtained from WHO as indicated in the pharmaceutical newsletter. Each participating

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country in the scheme should issue guidelines to all agents responsible for importing under its jurisdiction to explain the contribution of certification to the drug regulatory process and the circumstances in which each of three types of documents will be required. 1.CERTIFICATE OF PHARMACEUTICAL PRODUCTS : CERTIFICATE OF PHARMACEUTICAL PRODUCTS The certificate of a pharmaceutical product issued by the exporting country it is mainly used by the competent authority within an importing country in two situations: 1When the product in question is under consideration for a product license which is necessary for import and sale 2When administrative action is required to renew extend vary or review such a license. All requests for certificates should be channelled through the agent in the importing country and the product-license holder or other commercially interested party in the exporting country “ the applicant” The applicant should submit the following information for each product: Brand name Generic name International Non-proprietary Name where such exists. Name and address of manufacturing facility Formulation when no product license exists or when the formulation differs from that of the licensed product Product information for medical professionals and for patients as approved in the exporting country Labeling on retail and wholesale containers Retail packaging. The certificate can be issued by the competent authority in the exporting country only with the permission of the applicant and if different than the product-license holder. The certificate should be incorporated into the product-license application in the importing country. Once prepared it is transmitted to the requesting authority through the applicant. When any doubt arises about the status or validity of a certificate the competent authority in the importing country should request a copy direct from the certifying authority. In the absence of any specific agreement each certificate will be prepared exclusively in the working languages of the certifying authority. The applicant will be responsible for providing any notarized translation that may be required by the requesting authority. Since the preparation of certificates imposes a significant administrative load on certifying authorities the service may need to be financed by charges levied upon applicants. Supplementary attestations are obtainable only at the certifying authority and with the permission of the applicant. Example -certificate for pharmaceutical product No. of certificate Exporting certifying country: Importing requesting country: Name and dosage form of the product: Active ingredient and amount per unit dos: 1.Is the product licensed to be placed on the market for use in the exporting country

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