812.216.2 order of the Swiss Institute for therapeutic products on the simplified authorization of preparations based on allergens (order allergen, OAllerg) of December 11, 2009 (status March 1, 2010) the Council of the Swiss Institute for therapeutic products (Council of the Institute), under art. 14, al. 1, of the Act of 15 December 2000 on therapeutic products (ATP), under art. 6 of the Ordinance of 28 September 2001 on the Organization of the Swiss Institute for therapeutic products, given the Federal law of 6 October 1995 on technical barriers to trade, stop: Section 1 provisions general article 1 purpose this order regulates the conditions related to the simplified authorisation of placing on the market of preparations of allergens to human medicine.
It applies: a. to allergens-based preparations intended for diagnosis vivo; b. to preparations based allergen specific immunotherapy.
On the other hand, it does not apply to allergens-based preparations that contain allergens produced by DNA technology recombinant, or genetically modified organisms.
S. 2 applicable law provided that this order provides otherwise, the provisions of the following orders shall apply: a. order of the Swiss Institute for therapeutic products of 9 November 2001 on requirements for the authorisation of placing on the market of medicinal products (Oemed); b. order of the Swiss Institute for therapeutic products of 22 June 2006 on the simplified drug and the authorisation of medicines on ad (Vazv).
RS 812.212.22 RS 812.212.23 s. 3 definitions for the purposes of this order, means: a. allergen: a substance likely to trigger an allergic reaction or cause allergic disease; b. Preparation based on allergens: a drug that contains one or more allergen (s); c. Test patch or patch test: a test intended to highlight awareness to an allergen by application on the skin of a preparation basis of allergens; d. intradermal Test or prick-test : a test intended to highlight awareness to an allergen by application in the skin of a preparation based allergens; e. provocation Test: a test intended to highlight awareness to an allergen by oral, nasal, bronchial, or conjunctival preparation application allergens based; f. Diagnostic in vivo: implementation evidence of sensitization to an allergen or an allergy by the application of a preparation to allergens based patch or patch test testing , a test intradermal or prick-test or a provocation test, g. immunotherapy (STI) (also called desensitization or hyposensitization): the treatment of allergy by (e.g., oral or subcutaneous) repeated application of a preparation of allergens; h. specificity: the ability of the diagnostic in vivo to identify as such people who are not allergic reaction or sensitization to an allergen given; i. sensitivity : the ability of the diagnostic in vivo to identify as such by people who have an allergic reaction or sensitization to a given allergen.
Section 2 simplified authorisation art. 4 principles the preparations with a basis of allergens within the meaning of art. 1, al. 2, may be the subject of an atue.
Simplification consists in the fact that the documentation: a. may rely on articles published in the scientific literature; b. may refer to the documentation of another preparation based on allergens (preparation of reference).
S. 5 authorization based on the literature provided that the application for authorisation for placing on the market is based on the published scientific literature, the applicant must prove through a bibliography that detailed the components of the preparation of allergen: a. are commonly used for medical purposes and the claimed indication according to the mode of administration provided; ETB. have recognised efficacy and an acceptable level of safety.
S. 6 authorization based on the documentation of a reference preparation the authorisation issued for a preparation parent is granted to the holder of the authorisation of the reference preparation.
To obtain the authorisation of a preparation based on allergens, the applicant may refer to the preparation of reference documentation, provided: a. There are between allergens of this parent preparation and preparation of reference sufficiently close structural homology, etb. that raw materials have biological and physico-chemical characteristics comparable.
A close structural relationship exists in particular in the following peer groups: a. pollens of trees in the family of the order of the fagales betulaceae; b. pollens of trees of the Oleaceae family v. pollens of trees in the Cypress family Cupressaceae; d. pollen of grasses in the family Poaceae and its the pooideae subfamily; e. pollens of herbaceous; f. House of the species of the dermatophagoides dust mite.
In addition, the following conditions must be fulfilled: a. parent preparation and preparation of reference extracts are produced by the same manufacturer; b. the parent preparation and preparation of reference are produced by the same manufacturer; c. extraction and preparation parent and the reference preparation manufacturing processes are equivalent.
Section 3 Preparations with a basis of allergens for diagnosis in vivo Art. 7 proof of stability for a preparation of allergens for diagnosis in vivo proof of stability which must be provided in the context of the analytical tests, chemical and pharmaceutical literature provided for in art. 3, al. 1, let. f Oemed can rely on data relating to the preparation of reference, provided that the applicant can prove that the results shall apply by analogy to the parent preparation.
RS 812.212.22 s. 8 documentation on pharmacological and toxicological testing documentation on pharmacological and toxicological tests defined in art. 4 Oemed can be reset in bibliographic form, provided that the published scientific literature provide sufficient evidence.
RS 812.212.22 s. 9 documentation on clinical trials clinical trials set to art documentation. 5 Oemed must provide evidence in areas relevant for diagnostic products in vivo.
With regard to testing patch or patch tests, specificity, sensitivity and the clinical relevance of the preparation of allergens must be proven. The documentation may be purely bibliographic, insofar as the published scientific literature provide sufficient evidence.
In regards to intradermal tests or prick-tests and tests of provocation, should demonstrate, in addition to the proof required in the al. 2 above, the safety of the preparation of allergens. Documentation may rely on a preparation of reference data, provided that the applicant can prove that the results shall apply by analogy to the parent preparation.
RS 812.212.22 s. 10 information on the drug information for professionals referred to in art. 13 Oemed can replace the information intended for patients such as package leaflet.
Common to professional information can be drafted for a preparation of reference and related preparations related to him.
Common to professional information may, in justified cases be to patch or patch-testing of an applicant testing.
RS 812.212.22 Section 4 Preparations based on allergen for immunotherapy s. 11 proof of stability for allergens based preparations to the ITS, the proof of stability shall be provided according to the requirements of art. 7 s. 12 documentation on pharmacological and toxicological tests for allergens based preparations to the ITS, the literature on the pharmacological and toxicological tests must meet the requirements set out in art. 8 s. 13 literature on clinical trials clinical trials set to art documentation. 5 Oemed can rely on data from the reference preparation, where the claimant can prove that the results shall apply by analogy to the parent preparation.
RS 812.212.22 s. 14 information on medication information for common professionals and a common patient information may be written for a reference preparation and preparations related related to him.
Section 5 provisions finals s. 15 amendment of the law in force the amendment to the law in force is set in the annex.
S. 16 entry into force this order comes into force on March 1, 2010.
Annex (art. 15) the law in force the order of 22 June 2006 on the emoluments of the Swiss Institute for therapeutic products is amended as follows: annex c. 1, al. 2, let. l p, 8, let. f-j, 12, let. e to g, and let 13. d...
RS 812.214.5. The below change is inserted in the said order.
State on March 1, 2010