Applicant/licence holder This is the company submitting the application. Usually it is the owner of the trademark, where applicable. If the application results in a marketing authorization, this company becomes the holder of such authorization. Licence holder and marketing authorization holder are synonyms. For each product only one company can be the applicant/licence holder.
Application for certificate An application submitted by the MA holder to obtain a certificate describing the regulatory status of a given product or the GMP status of manufacturing premises. Product certificates are usually requested in order to export products. When product certificates are issued, it is important that no less than the minimum information required should be released. For a pharmaceutical product, the minimum information required is what established in the WHO Certification Scheme:
• Presence of an MA in the exporting country
• Reasons for not having an MA, if applicable
• Conditions under which MA has been issued (i.e., validity of MA, full product information, and dispensing category)
• GMP profile of manufacturer
• Statement on regularity of inspection to manufacturing of the dosage form object of the certificate
The elements contained in a certificate of this type complement each other. Certificates including less than this information may lend themselves to misinterpretation.
Distributor In some countries, regulations establish that importation or wholesale of a given drug product can be done only by selected companies. A drug registration system should accept several different distributors. Up to fifty different distributors can be related to each individual drug product in the WHO system.
Generic product See multi-source product.
Innovator product Generally, the innovator pharmaceutical product is that which was first authorized for marketing, usually as a patented drug, on the basis of documentation of efficacy, safety, and quality (according to contemporary requirements and criteria). In the case of drugs that have been available for many years, it may not be possible to identify an innovator pharmaceutical product.
Manufacturer This is any company that in some way participates in the manufacturing of a drug product. A drug registration system should accept several different manufacturers for the same drug product (the WHO system can accommodate up to 50), permitting specification of the role for each of them, e.g., source of starting materials, preparation of semifinished product, formulation, labelling, repackaging, etc. The fact that the software permits several manufacturers to be listed should not mislead users from the widely accepted and recommended understanding that the manufacturer who last manipulated the drug product, albeit only for repackaging, and releases it for marketing bears the entire responsibility for the quality of the product and for ensuring that any starting material, intermediate, or finished dosage form meet the required standards.
Multi-source product A multi-source pharmaceutical product, also called a generic product, is a product pharmaceutically equivalent to an innovator product (see definition above). It is usually intended to be interchangeable with the innovator product. It is usually manufactured without a licence from the innovator company and marketed after expiry of patent or other exclusivity rights. A multi-source product can be sold under a brand name (sometimes called a branded generic) or under its generic name (usually the INN of its active ingredient).
• Company operating authorization: This refers to an authorization given to company to perform a given activity falling under the control of the drug regulatory authority. It is also called an operating licence or permit. If a company carries out more than one activity, it may have separate operating licences for each individual activity.
• Other types of company-related authorization: In some countries, the regulatory authority needs to record information linking companies with other institutions, e.g., Ministry of Industry, Ministry of Finance, or Customs. These pieces of information are called various things, e.g., Ministry of Industry Number, Customs Number, etc.
PI See Product Information
Product Information A complete document giving indications, contraindications, mode of administration, adverse reactions, precautions, use in selected population groups (newborns, infants, children, pregnant/breast feeding women, elderly, other as appropriate), and any other information that should be considered in connection with the clinical use of the product. The PI is the reference document on the basis of which prescribing information, patient information, and promotion materials must be prepared.
Summary of Product Characteristics See Product Information.
Variation Any change made to selected information related to an existing, valid marketing authorization. Depending on established regulations, the type and extent of variations permitted vary from country to country. Variations admitted in some countries entail, elsewhere, issuance of a new marketing authorization and cancellation of the previous one. To accommodate such a variety of requirements, the registration software should permit recording variation of all marketing authorization data except the number and validity. In all cases the history of variations must be recorded and be available for future reference.