PHARMACEUTICAL DOSSIER DEFINITION FULL
PHARMACEUTICAL DOSSIER DEFINITION REGISTRATION
PHARMACEUTICAL DOSSIER DEFINITION LICENSE

If marketing authorisation is lacking in the exporting country, information about the reasons for this.

Appended summary of technical basis on which the product has been licensed (if required by the issuing authority).

PHARMACEUTICAL DOSSIER DEFINITION LICENSE

Number of product license (including license holder details, license holder's involvement in manufacturing if any) and date of issue, if applicable.

PHARMACEUTICAL DOSSIER DEFINITION REGISTRATION

Information on registration (licensing) and marketing (presence on the market) status of the product in the exporting country.Name, dosage (pharmaceutical) form and composition of the product (active ingredient(s) and amount(s) per unit dose).The content of CPP consists of the following main data:

PHARMACEUTICAL DOSSIER DEFINITION FULL

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. However, regulatory practices often vary in importing countries. 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 labelling requirements, and to assess bioequivalence and stability data if necessary. Ĭertification 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. The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorisation) or renewal (prolongation) of registration, with the scope of commercialisation or distribution in that country. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has instituted standards for this purpose but it is unclear how the ex-ICH countries operate their health regulators. The CPP is mentioned in World Trade Organization documents, although the tightly regulated products are subject to bilateral trade agreements or regional trade agreements. A CPP is issued for a single product, because manufacturing arrangements and approved information for different pharmaceutical forms and strengths can vary. The certificate of pharmaceutical product (abbreviated: CPP) 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 often mentioned in conjunction with the electronic Common Technical Document (eCTD).

Pharmaceutical dossier definition