Certificate of pharmaceutical product

Certificate of pharmaceutical product

The certificate of pharmaceutical product (abbreviated: CPP or CoPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country. It is issued for a single product only, because manufacturing arrangements and approved information for different pharmaceutical forms and strengths can vary.[1]

Contents

Scope

The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licencing, authorisation) or renewal (prolongation) of registration, with the scope of commercialisation or distribution in that country.[1] Certification has been recommended by WHO to help undersized drug regulatory authorities or drug regulatory authorities without proper quality assurance facilities in importing countries to assess the quality of pharmaceutical products as prerequisite of registration or importation.

In the presence of such CPP, WHO recommends to national authorities to ensure that analytical methods can be confirmed by the national laboratory, to review and if necessary to adapt product information as per local labeling requirements, and to assess bioequivalence and stability data if necessary.[2]

However, regulatory practices often vary in importing countries. Thus, in addition to CPP, assessment of application dossiers to support drug registrations, with different levels and complexity of requirements are considered necessary to satisfy full assurance on the appropriate quality of drugs.[3]

Content and format

The content of CPP consists of the following main data:

  • Exporting (certifying country):
  • Importing (requesting country):
  • Name and dosage (pharmaceutical) form of the product (active ingredient(s) and amount(s) per unit dose)
  • Information on registration (licensing) and marketing (presence on the market) status of the product in the market for use in the exporting country
  • Number of product licence (including licence holder details, licence holder’s involvement in manufacturing if any) and date of issue, if applicable.
  • Appended summary of technical basis on which the product has been licensed (if required by the issuing authority)
  • Appended current product information.
  • Details on the applicant for the CPP.
  • If marketing authorization is lacking in the exporting country, information about reasons.

When applicable, information if the manufacturing site is periodically inspected by certifying authority and if the manufacturing site complies with Good Manufacturing Practice (GMP) as recommended by WHO.

Although issuing authorities claim that their CPP conform to WHO format (a statement to confirm whether or not the document is issued in the format recommended by WHO should be included in the certificate), their format and content may vary from an issuing country to another. Also, some authorities do not issue CPP if the respective drug is not licenced in the exporting country (e.g. Italy).

Special considerations in importing countries

Most competent authorities in importing countries require CPP to be issued by the country of origin.

Also, even though this certificate is released in its original form, addressed to a specific importing country and stamped with the seal of issuing authority on all pages, many authorities in importing countries may unnecessarily request authentication of such a document in the form of legalization by corresponding embassy in the exporting country or by apostillation.

References

  1. ^ a b "WHO | Model certificate of a pharmaceutical product". Who.int. 2009-03-13. http://www.who.int/medicines/areas/quality_safety/regulation_legislation/certification/modelcertificate/en/. Retrieved 2010-07-26. 
  2. ^ World Health Organization. Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Poducts: A Manual for Drug Regulatory Authorities. - Regulatory Support Series No. 005, WHO/DMP/RGS/98.5, Geneva, 1998.
  3. ^ World Health Organization. Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. WHO/DAP/94.21, Geneva, January 1995.

External links


Wikimedia Foundation. 2010.

Игры ⚽ Поможем решить контрольную работу

Look at other dictionaries:

  • Certificate of a Pharmaceutical Product — Ein Certificate of a Pharmaceutical Product (CPP; deutsch: Zertifikat bzw. Bescheinigung für ein Arzneimittel bzw. ein pharmazeutisches Produkt) ist eine von nationalen Gesundheitsbehörden auf Antrag ausgestellte Bescheinigung über die… …   Deutsch Wikipedia

  • Pharmaceutical industry in the People's Republic of China — The pharmaceutical industry is one of the leading industries in People s Republic of China, covering synthetic chemicals and drugs, prepared Chinese medicines, medical devices, apparatus and instruments, hygiene materials, packing materials, and… …   Wikipedia

  • Pharmaceutical industry in China — The pharmaceutical industry is one of the leading industries in China, covering synthetic chemicals and drugs, prepared Chinese medicines, medical devices, apparatus and instruments, hygiene materials, packing materials, and pharmaceutical… …   Wikipedia

  • Supplementary protection certificate — In European Union member countries, a supplementary protection certificate (SPC) is a sui generis , patent like, intellectual property right. This type of right is available for medicinal products, such as drugs, and plant protection products,… …   Wikipedia

  • CPP — and cpp may refer to: Contents 1 Companies 2 Political parties and organizations 3 Science, technology and machine …   Wikipedia

  • Copp — or Copps may refer to: People Doug Copp, promoter of the Triangle of Life, a technique he claims reduces casualties in earthquakes Geraldine Copps (born 1925), Canadian politician Harold Copp, a Canadian scientist Michael Copps (born 1940), on… …   Wikipedia

  • CPP — Die Abkürzung CPP steht für: die Dateiendung für in der Programmiersprache C++ verfasste Programm Quelltexte Chondropathia patella, einen Schaden am Gelenksknorpel der Kniescheibe Cerebraler Perfusionsdruck in der Intensivmedizin CPP Inc.… …   Deutsch Wikipedia

  • Marketing authorization — Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing (also called licensing, registration, approval, etc.), obviously finalized by granting of a document also called marketing authorization… …   Wikipedia

  • Orphan drug — An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease. The assignment of orphan status to a disease and to any drugs developed… …   Wikipedia

  • Criticism of intellectual property — Critics of the term intellectual property argue that the increased use of this terminology coincided with a more general shift away from thinking about things like copyright and patent law as specific legal instruments designed to promote the… …   Wikipedia

Share the article and excerpts

Direct link
Do a right-click on the link above
and select “Copy Link”