Based on the legislatively defined sets of "basis for change" documents, changes in the definition of a Medicinal Product - Preparation Production Chain related to the Description and Composition of the Medicinal Product initiate the following variations that have to be reported to the competent Health Authorities:

• B.II.a.1 Change or addition of imprints, bossing or other markings including replacement, or addition of inks used for product marking

  • a) Changes in imprints, bossing or other markings

  • b) Changes in scoring/break lines intended to divide into equal doses

• B.II.a.2 Change in the shape or dimensions of the pharmaceutical form

  • a) Immediate release tablets, capsules, suppositories and pessaries

  • b) Gastro-resistant, modified or prolonged release pharmaceutical forms and scored tablets intended to be divided into equal doses

  • c) Addition of a new kit for a radio-pharmaceutical preparation with another fill volume

• B.II.a.3 Changes in the composition (excipients) of the finished product

  • a)   Changes in components of the flavouring or colouring system

    • 1. Addition, deletion or replacement

    • 2. Increase or reduction

    • 3. Biological veterinary medicinal products for oral use for which the colouring or flavouring agent is important for the uptake by target animal species

  • b)   Other excipients

    • 1. Any minor adjustment of the quantitative composition of the finished product with respect to excipients

    • 2. Qualitative or quantitative changes in one or more excipients that may have a significant impact on the safety, quality or efficacy of the medicinal product

    • 3. Change that relates to a biological/immunological product

    • 4. Any new excipient that includes the use of materials of human or animal origin for which assessment is required of viral safety data or TSE risk

    • 5. Change that is supported by a bioequivalence study

    • 6. Replacement of a single excipient with a comparable excipient with the same functional characteristics and at a similar level

• B.II.a.4 Change in coating weight of oral dosage forms or change in weight of capsule shells

  • a) Solid oral pharmaceutical forms

  • b) Gastro-resistant, modified or prolonged release pharmaceutical forms where the coating is a critical factor for the release mechanism

• B.II.a.5 Change in concentration of a single-dose, total use parenteral product, where the amount of active substance per unit dose (i.e. the strength) remains the same

• B.II.a.6 Deletion of the solvent/diluent container from the pack