Applications for a marketing authorisation under the simplified authorisation procedure must contain the following data and documents for the following medicinal products:
a. Medicinal products referred to in Article 14 paragraph 1 letter abis:
1. the data and documents referred to in Article 11 paragraphs 1 and 2 letter a numbers 1–4; the data referred to in Article 11 paragraph 2 letter a number 2 may be replaced by a compilation of equivalent scientific evidence,
2. proof of the marketing authorisations of the foreign comparator product;
b. Medicinal products referred to in Article 14 paragraph 1letter ater:
1. the data and documents referred to in Article 11 paragraphs 1 and 2 letter a numbers 1, 3 and 4,
2. an assessment of the risks,
3. proof of 30 or 15 years of medical use;
c. Medicinal products referred to in Article 14 paragraph 1 letter aquater:
1. the data and documents referred to in Article 11 paragraphs 1 and 2 letter a numbers 1, 3 and 4,
2. an assessment of the risks,
3. the cantonal marketing authorisation;
d. Medicinal products referred to in Article 14 paragraph 1 letter b: the data and documents referred to in Article 11 paragraphs 1 and 2 letter a; the data referred to in Article 11 paragraph 2 letter a number 2 may be replaced by equivalent data in accordance with specific therapy approaches, in particular by bibliographical evidence of efficacy and safety, or by evidence of use;
e. Medicinal products referred to in Article 14 paragraph 1 letter cbis: the data and documents referred to in Article 11 paragraphs 1 and 2 letter a; the data referred to in Article 11 paragraph 2 letter a number 2 may be replaced by bibliographical evidence of efficacy and safety, or by evidence of use.
Throughout the period of marketing authorisation of medicinal products referred to in paragraph 1 letter a, the following information on the foreign comparator product shall be submitted to the Agency without being requested:
all internationally recorded safety signals;
all interim reports and final results of the foreign regulatory authority.
0 commentaries
No commentaries are available for this article yet.