Certificate of a Pharmaceutical Product

Israel is a signatory to the WHO s Certification Scheme and the desired format of the certificate is that of its Certificate of a Pharmaceutical Product. Certain additional elements are required and are delineated further on. These elements have to be appended to the certificate. The appendices normally will be prepared and filled in by the manufacturer and verified by the relevant authorities. Other formats of certificates will be accepted as long as all the required elements are included. 

This application form is for a Certificate for Exporter of Medicinal productx for human use only. (The Certificate for Exporter of Medicinal Products has also been referred to as the Certificate of a Pharmaceutical Product or Free Sale Certificiate.)... 

Certificate of a Pharmaceutical Product (CPP) according to the format issued by the World Health Organization (WHO). 

A WHO-type certificate of a pharmaceutical product (CPP) issued by one of the regulatory authorities of ICH regions YES NO... 

The applicant must apply for permission to manufacture or import a pharmaceutical product as a sample for registration the information on the labels and inserts must also be submitted to the FDA. In the case of a pharmaceutical product which is not yet registered in Thailand, a certificate of free sales issued by the country of origin is required. The same criteria are applied to new formulas or new combination pharmaceutical products. 

Bulk drug A chemical substance intended to be used in the manufacture of a pharmaceutical product with a products certificate required by the Drug Administration Law of the People s Republic of China. 

In 1984, the USA adopted a law which enabled the ifetime of certain American patents to be extended, iccording to this law, it is possible to obtain a maximum xtension of 5 years to holders of pharmaceutical patents /hen the marketing of a pharmaceutical product has been elayed in its registration by the FDA. In 1988, Japan has dopted a law which enables the life of a pharmaceutical atent to be extended for a period of 2 to 5 years. France and aly adopted a Certificate of Complementary Protection of harmaceutical patents in 1990. 

When materials are received to be used in the manufacture of a pharmaceutical product, an inspection (and possible testing) is usually necessary before the materials are accepted. Materials may be stored in a separate quarantined area until they are released and approved for use. The use of certified suppliers has allowed some materials to be received and accepted without additional inspection or testing. The certified supplier may provide a certificate of analysis dociimenting that the material meets the required specifications. Certified suppliers are usually audited to insure that they meet the requirements for certification of the customer. 

The Medicines Act 1968 included the definitions of a clinical trial and of a medicinal product. Clinical studies involving healthy volrmteers did not meet this definition of a clinical trial and, as a result, did not come under the remit of regulatory controls. Such studies were subject to self-regulation by the pharmaceutical industry. Consequently, only the clinical trials in patients had to be covered by a clinical trial certificate (CTO. 

Only three countries, Tunisia, Uganda and Zimbabwe, do not issue a GMP certificate. The drug regulatory authorities in these three countries do conduct GMP inspections, but do not issue a specific document which indicates that a manufacturing plant has attained GMP standards. The MCAZ does, however, provide a GMP certificate at the manufacturer s request to facilitate international registration and export of products. In Malaysia, various types of certificates are issued GMP certificates Certificate of Pharmaceutical Product for export and Certificate of Free Sale for medical devices and cosmetic products. Cyprus has no clear criteria for issuing a GMP certificate instead. 

Good Manufacturing Practice and certification of starting materials for the industrial manufacture of medicinal products. Concept paper on a Community regulatory framework , 1995 European Commission, Directorate General IE, Industry Consumer Goods Industries III/E/3 Pharmaceuticals, July. 

In most cases, ointments, suppositories, ophthalmic, and parenteral products assume the color of their ingredients and do not contain color additives. In addition to esthetics and the certification status of a dye, a formulation pharmacist must select the dyes to be used in a particular formula on the basis of the physical and chemical properties of the dyes available. Of prime importance is the solubility of a prospective dye in the vehicle to be used for a liquid formulation or in a solvent to be employed during a pharmaceutical process (such as when the dye is sprayed on a batch of tablets). In general, most dyes are broadly grouped into those that are water-soluble and those that are oil-soluble few, if any, dyes are both. 

All formulations for administration to humans must be prepared in compliance with good manufacturing practice (GMP) and the certificates of analysis must be provided. The European Clinical Trials Directive requires that details of the formulations be provided to, and approved by, regulatory authorities and a qualified person at the investigator site(s). In principle, the Directive has been in force throughout the EU since May 2004 though it has been implemented at various times in different member states. The Directive applies to healthy volimteer as weU as patient studies. The requirements for pharmaceutical products for administration to humans are summarised in Box 4.6. 

Australia and the EC have entered into a Mutual Recognition Agreement (MRA) on conformity assessment of medicinal products. The TGA will accept a certificate of GMP compliance of a manufacturer issued imder this MRA by the official inspection services of the EU countries. This follows on from Australia s work over many years with the Pharmaceutical Inspection Convention, now known as the PIC/S. 

Before a new pharmaceutical product can be tested in clinical trials, the test product, its labelling and the intended trials must be approved. This is usually done by the same authority that is responsible for the market approval of the final product. The formal procedures to obtain permission for clinical trials vary. Some countries require only a notification to the authority, which may then object within a certified period, other countries require a formal application in order to obtain approval, e.g. by issuing a Clinical Trial Certificate (CTC), before the trials can commence. 

Examples are EU and/or FDA for a pharmaceutical industry selling products to the European Union and the United States, respectively EPA for environmental issues in the United States, military, hospital, and nuclear standards for these industries. Some standards are voluntary, e.g., standardization/accreditation programs such as ISO. Here the industry has asked for a certification or accreditation according to the standard. There may also be internal standards in any company based on a combination of external standards and internal standards. 

Effective on January 1, 1993, Supplementary Protection Certificates (SPC), a system of providing extended protection for pharmaceutical products, was created by the European Community (EC). Such certificates do not actually extend the patent per se but confers protection for the product covered by the granted... 

Application for a Quality Certificate to the Institute for Standardization and Control of Pharmaceuticals (See a translation of the application form in Appendix 3). With this application, samples of the finished product and of the active substance(s) and their respective certificates of analyses must be submitted. The final approval of the application for registration is contingent upon the availability of the Quality Certificate. Separate applications have to be submitted for each dosage strength. 

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