Homeopathic veterinary medicinal products – simplified registration application

 Provisions

 Provisions to use the simplified registration application:

• The medicinal product is a homeopathic medicinal product as defined in The European Pharmacopoeia.​The route of administration is described in the European Pharmacopoeia, or if not found there, in a pharmacopoeia officially in use in a Member State.
• ​No therapeutic indication appears on the labelling of the medicinal product or in any information relating hereto.
• There is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product may not contain more than one part per 10 000 of the mother tincture/homeopathic stock.
• In order to be used in food producing animal species it is required that all the substances included in the manufacturing of the homeopathic stock(s) are found in the list for allowed substances in the “Forskrift om grenseverdier for legemiddelrester I næringsmidler for dyr” (national regulation for maximum residue limits for active substances in food producing animals).

The simplified registration procedure is described in "forskrift om legemidler dyr" and Regulation 2019/6. Homeopathic medicinal products that do not fulfill the provisions it is necessary to apply for a regular marketing authorisation.

Application for registration should include

Every application for the simplified registration of homeopathic medicinal products should include application form with annexed documents and mock-ups, see references to following points 3 and 4 below.

The Norwegian Regulation on Medicinal Products "legemiddelforskriften" was amended 11.11.2016. The documentation to be submitted has been changed, if the application is based on a registration in another EEA country. For more information about this, see point 5 below.

If the homeopathic medicinal product registration in other EEA country does not meet the requirements in Directive 2001/82/EC, documentation needed to be submitted by the Applicant is described in section 6 below.

The Applicant/registration holder is responsible for the submitted documents and data is correct. This is applicable for the application, annexes  and documentation.

Application form with annexes

There is no specific application form specific for registration of homeopathic veterinary medicinal products.  The application form Application form homeopathic medicinal products for human use can be used. The applicant shall inform the NoMA that the application concerns a homeopathic veterinary medicinal product, referring to Art 17 Directive 2001/82/EC. In the cover letter of the application or in the application form the specie(s) for which the product is intended shall be named. Use one application form for each pharmaceutical form of the product concerned. An application may consist of several degrees of dilution from the same homeopathic stock. Name all dilutions in the first page in the application form.  

The following documents should be submitted with all applications, see the Application form point 3 «annexed documents».

• Proof of establishment of the applicant in the EEA (Annex 4.3) Manufacturing Authorsiation. The Manufacturing Authorisation shall include a license to produce of homeopathic medicinal products (Annex 4.6).
• Flow-charts for all sites involved in manufacturing process of the medicinal product and the homeopathic stock (Annex 4.8).
• GMP certificate (Annex 4.9).
• Copy of registration in other EEA countries (Annex 4.15).
• QP Declaration (4.22).
• Labeling for packaging material (mock-up) 

Enclose other annexes as letter of authorisation for communication (Annex 4.4) and Ph. Eur. Certificate(s) of suitability for TSE (Annex 4.12) where appropriate.

In the application form section 3 information on whether an application for the homeopathic medicinal product is pending, withdrawn or refused in other countries should be given. In this section the applicant should state any suspension/revocation imposed in countries where the homeopathic medicinal product is registered.

Product Information and naming of the medicinal products

Mock-ups of outer and immediate packaging has to be included in the application for registration of the homeopathic medicinal products cf. the Norwegian legislation "legemiddelforskriften" § 3-22 first paragraph, letter f. Mock-ups must be in Norwegian, Danish, Swedish or English, or a multilingual mock-up where one of the mentioned languages is included.

Note that these mock-ups has to be in accordance with "legemiddelforskriftens § 3-39.

It is possible to apply for using a Norwegian sticker to hide the foreign language. A manufacturer with a valid manufacturing authorisation has to do this.

A Norwegian mock-ups or a multilingual mock-ups where Norwegian is one of the languages has to be used within 3 years.

Product Information –guideline for applicants will be updated in 2017.

If the homeopathic medicinal products is composed of one stock, the product name should be the scientific name of the stock followed by the degree of dilution. If the homeopathic medicinal product is composed of two or more stocks, the scientific names of the stocks on the labelling may be supplemented by an invented name. The product name must be approved by NoMA. For further information see Guideline for the naming of medicinal products

Registration on the grounds of a registration in another EEA country

According to the Norwegian Regulation on Medicinal Products "legemiddelforskriften" §3-22A a registration of a homeopathic medicinal product in another EEA country may be the ground for registration in Norway. The registration in the other EEA country should comply with the requirements in Directive 2001/82/EC. The applicant is required to have the documentation that makes the basis for registration in the other EEA country available for the NoMA. The NoMA may on particular grounds, require that the applicant submit the documentation that makes the basis for the registration.

Application form including annexes and mock-ups should be submitted, see point 2 and 3 above.

If an assessment report from another EEA country is available, the NoMA encourages the applicant to enclose the report.

The applicant will be requested to submit all documentation, when the NoMA is in doubt if the registration is within the scope of Directive 2001/82/EF. For homeopathic stock of biological origin it is mandatory to submit all documentation according to the Norwegian Regulation on Medicinal Products "legemiddelforskriften" § § 3-21 and 3-22.

Some countries has had transitional arrangements and national adjustments before implementing the simplified registration procedure. Homeopathic medicinal products placed on the market should comply with the requirements in the current Directive regarding safety, quality and homeopathic tradition.  A registration granted according to previous arrangements and lower requirements than stated by the current directive will not be considered sufficient.  

The NoMA will as a starting point accept the lowest dilutions registered in another EEA country. If you apply for a lower potency/dilution in Norway then registered in the EEA, the NoMA will require that the applicant submit safety documentation. In order to be used in food producing animal species it is required that all the substances included in the manufacturing of the homeopathic stock(s) are found in the list for allowed substances in the "Forskrift om grenseverdier for legemiddelrester i næringsmidler for dyr" (national regulation for maximum residue limits for active substances in food producing animals).

Application for registration in other cases

Application form including annexes and mock-ups should be submitted, see point 3 and 4 above.

Documentation on quality

For the requirements, see the Norwegian Regulation on Medicinal Products legemiddelforskriften § §3-21 and 3-22. See guidance on Homeopathic medicinal products working group (HMPWG).

Documentation on safety

For requirements, see the Norwegian Regulation on Medicinal Products legemiddelforskriften§3-21. A condition for using the simplified registration procedure for homeopathic medicinal products for food producing animals is that all the substances included in the manufacturing of the homeopathic stock(s) are found in the list for allowed substances in the "Forskrift om grenseverdier for legemiddelrester I næringsmidler for dyr" (national regulation for maximum residue limits for active substances in food producing animals).

Justification of homeopathic use of the stock

The homeopahtic use of the stock(w) should be justified based on adequate bibliography.