Registration of homeopathic medicinal products for human and veterinary use – Variations, renewals, withdrawals and Sunset Clause

Genera​l information

The registration holder shall follow up the medicinal product and suggest necessary variations. The holder is committed to inform the NoMA about any prohibitions and any limitations that are imposed in an EEA country where the product is approved and distributed. The registration holder is obliged to provide the NoMA with information about the distribution of the medicinal product. The legislation covering pharmacovigilance are not in force for homeopathic medicinal products.

Variations

The registration holder shall keep himself updated on the development of the relevant medicinal field.  If the technical development proceeds in a direction that makes it necessary to make changes in the methods used for manufacturing or quality control, the registration holder is obliged to apply for a variation. This is also applicable in the case of new safety data.

If it is necessary to make modifications in the documentation and/or the packaging materials, the registration holder shall submit an application to the NoMA. If the registration holder wishes to make changes to the product, an application for a variation shall be submitted to the NoMA for approval.
Examples of modifications that might be relevant is changes in:

• Manufacturing method
• Composition of the product
• Packaging material or packaging size
• Quality standards or analytical methods
• Manufacturer or supplier of excipients, raw materials, stock, or the final product
• Responsibility for batch release
• Registration holder
• The name of the product
• The appearance of the mock-ups

New safety data shall also be submitted to the NoMA. More information about application for variations will be published in 2017.

Renewals

A registration is valid for 5 years, and can be renewed based on an application. For the application for renewal to be valid it shall be submitted at least 9 months before the end of the registration period, according to “Forskrift om legemidler” i.e. Norwegian Medicinal Products Regulation, § 3-57.

Withdrawal of registration

The NoMA may withdraw a registration in cases where the:

• product no longer fulfills the requirements for quality and safety
• information that was given in connection with the application is incorrect
• production does not proceed in accordance with the submitted documents
• quality is not controlled according to approved specifications

For supplementary information please refer to “Forskrift om legemidler” i.e. Norwegian Medicinal Products Regulation.

Sunset Clause

Registration of a homeopathic medicinal product that within three years of its granting is not followed by the actual placing on the market of the registered product shall cease to be valid. When a registered product previously placed on the market is no longer actually present on the market for a period of three consecutive years, the registration for that product shall cease to be valid.