Judgment;Summary — ECLI:EU:C:2020:804
Date: 2020-10-08
Language of the case: German
Court formation: Fourth Chamber
Subject matter: Free movement of goods;Measures having equivalent effect;Quantitative restrictions
Procedure: Reference for a preliminary ruling
Origin: Germany

summary of the medicinal product’s 
characteristics approved in the context of the authorisation and in the following 
order: 
… 
4. clinical indications 
… 
b) dosage and type of administration for adults and, in so far as the medicinal 
product is intended for administration to children, for children, [Or. 13] 
…’ 
31 If the authority intends to refuse consent to a notification of amendment, it 
shall bear the burden of explanation and proof in respect of the existence of 
grounds for rejection […]. 
32 In that case, the criteria for the decision are the grounds for refusing to grant 
authorisation listed in the first sentence of Paragraph 25(2) of the AMG. Points 1 
and 2 of the provision read as follows: 
‘The competent higher federal authority may refuse authorisation only if 
1. the documents submitted, including such documents as are to be submitted 
pursuant to a regulation of the European Community or the European Union, 
are incomplete, 
2. the medicinal product has not been sufficiently tested in accordance with the 
confirmed state of scientific knowledge in each case or the other scientific 
information material under Paragraph 22(3) does not correspond to the 
confirmed state of scientific knowledge in each case, 
KOHLPHARMA AND FEDERAL REPUBLIC OF GERMANY 
 
11 
3. …’ 
33 The questions that are set out in the operative part of the order and are 
relevant to the decision in the present dispute cannot be answered with sufficient 
certainty on the basis of the previous case-law of the Court of Justice of the 
European Union and by interpretation of Articles 34 and 36 TFEU having regard 
to Directive 2001/83/EC, and are therefore to be referred to the Court of Justice 
for a preliminary ruling. 
[…]