Homeopathic medicinal products for human use – 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 medicinal product is administered orally or externally*.
• 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 either more than one part per 10 000 of the mother tincture or more than 1/100th of the smallest dose used in allopathy.

*The Norwegian Medical Products Agency (NoMA) defines internal and external use in accordance with the Nordic tradition, as follows: "Medicinal products for internal use  are those meant for use into the body or through the skin or mucosa, i.e. those which are administered orally, nasally, through the mammary gland openings, through the urethra, vaginally, anally and those for ocular use. This also includes medicinal products for application into tissues or cavities opened through an invasive procedure and surrounded by fibrous connective membranes. All other medicinal products are to be considered as medicinal products for external use". Thus, the only type of medicinal product for internal use for which a simplified registration procedure can be applied for are medicinal products for oral use.

The homeopathic medicinal product must fulfill the provisions for simplified registration in order to be sold on the grounds of submitted application. For internal use, only medicinal products administrated orally fulfills this provision. The NoMA defines externally use as preparations for application on the skin. Eye drops, ear drops, suppositories, vaginal preparations and nasal drops are examples of pharmaceutical forms which cannot be registered by the simplified registration in Norway.  For homeopathic medicinal product that do not fulfill the provisions it is necessary to apply for a regular marketing authorisation.

The simplified registration procedure is described in "Legemiddelforskriften" i.e. the Norwegian Medicinal Products Regulation, §3-21 to § 3-22, and directive 2001/83/EC Art 14-15.

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 2001/83/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

Application form  for homeopathic medicinal products should be used. 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 the medicinal product

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 "legemiddelforskriftens" § 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

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 2001/83/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 2001/83/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.

Application for registration in other cases

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

Documentation on safety

For the requirements, see the Norwegian Regulation on Medicinal Products legemiddelforskriften § 3-21. Information on "First safe dilution" is published on the website of the Homeopathic Medicinal Products Working Group (HMPWG). No further documentation is necessary if the homeopathic stock is noted on the list published by HMPWG, and the degree of dilution of the stock is according to this list.

If the homeopathic stock is not on this list, documentation on the safety must be submitted to the NoMA. See guidance on Homeopathic medicinal products working group (HMPWG) web site.

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).

Justification of homeopathic use of the stock

The Homeopathic Medicinal Products Working Group (HMPWG) has published lists on stocks for which homeopathic use has been justified: "List of justified stock". If the homeopathic medicinal product contains stock or stocks, which are listed on "list of justified stocks", a reference to the list can be made in the application. In such cases, it is not mandatory to submit addition documentation on the homeopathic use. 

If the homeopathic stock is not on this list, documentation on the homeopathic use of the stocks must be submitted to the NoMA. See guidance on Homeopathic medicinal products working group (HMPWG).

Submission and format

The application should be submitted electronically. The preferred delivery option is the European submission platform CESP. The NoMA also accepts submissions by Eudralink/email to post@noma.no or by CD/DVD. The applicant should only use one method of delivery per application. 

Module 1 consist of application form for homeopathic medicinal products with annexes, mock-ups and if available assessment report from another EEA country. If documentation is required submitted, this should be organised in modules, reference is made to application form section 1.4. If the application sent to another EEA country was in the "old format", this format can be submitted  to the NoMA without changing to the Common Technical Document format (CTD).

Questions related to the format for submission of application for a simplified registration of a homeopathic medicinal product can be directed to pk@noma.no.