Dossier for substances registration

Досье для регистрации субстанций List of documents for registration of substances

Part I. Summary of dossier.

І А. Administration data

  • The content of the registration dossier
  • Application form
  • The quality certificate for three batches of the substance or one certificate for one batch, accompanied by the obligation to submit the certificates for two others batches, as soon as they will be available (all certificates shall be submitted related to each applied manufacturing site).

І В 2. Propositions concerning samples/mock-ups of the packaging, labelling.

Part ІІ. Chemical, pharmaceutical and biological documentation.

ІІ С. Starting materials control methods

ІІ С 1. Active substance

ІІ С 1.1. Specifications, standard methods and validity methods data

ІІ С 1.2. Scientific data

ІІ С 1.2.1. Range (nomenclature)

ІІ С 1.2.2. Description

ІІ С 1.2.3. Manufacture

ІІ С 1.2.6. Impurities

ІІ С 1.2.7. Batch analysis

ІІ С 3. Packaging material (internal/external packaging)

ІІ F. Stability

ІІ F 1. Stability test methods of active substance and their validation (if appropriate)

All materials shall be submitted in Ukrainian or Russian. If materials lack some parts of documentation, the reason under the relevant headline in relevant place shall be stated. For approbation of test methods of substance quality the samples, reference substances with batch certificates, including manufacturing date, terms and storage conditions, may be required.

For substances of animal origin the following additional information shall be submitted in Part II C 1:

  • the data related to spices, age, dietary intake of animals, from which the raw material is obtained;
  • the data related to the tissue category, from which raw material for manufacturing of medicinal product is obtained, in the view of its safety related to the prion content;
  • the technological scheme of the processing of raw material with the indication of extragents, temperature regime, etc;
  • the control methods of starting material, including methods of prions detection in the finished product (when appropriate).