¹ 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.

² 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:

a.

all internationally recorded safety signals;

b.

all interim reports and final results of the foreign regulatory authority.