Commentaries: Art. 14a

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 a^bis: 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 a^ter: 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 a^quater: 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 c^bis: 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:
1. all internationally recorded safety signals;
2. all interim reports and final results of the foreign regulatory authority.

Art. 14a

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