EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
Annexes Del. Act Safety Features  
[…](2015) XXX  draft  
ANNEXES 1 to 4  
  
ANNEXES  
I to IV  
to the  
Commission Delegated Regulation (EU) No .../... of XXX  
supplementing Directive 2001/83/EC of the European Parliament and of the Council 
with regard to the detailed rules for the safety features appearing on the packaging of 
medicinal products for human use   EN 2   EN ANNEX I  
List of medicinal products or product categories subject to prescription that shall not 
bear the safety features, referred to in Article 4 5(1) 
 
Name of active substance or product category  Pharmaceutical 
form  Strength  Remarks  
Homeopathic medicinal products  Any Any  
Radionuclide generators  Any Any  
Kits Any Any  
Radionuclide precursors  Any Any  
Advanced therapy medicinal products  which 
contain or consist of tissues or cells  Any Any  
Medicinal gases  Medicinal gas  Any  
Solutions for parenteral nutrition having  an 
anatomical therapeutical chemical (‘ATC’) code 
beginning with B05BA  Solution for 
infusion  Any  
Solutions affecting the electrolyte balance having 
an ATC code beginning with B05BB  Solution for 
infusion  Any  
Solutions producing osmotic diuresis having an 
ATC code beginning with B05BC  Solution for 
infusion  Any  
Intravenous solution  additives having  an ATC 
code beginning with B05X  Any Any  
Solvents and diluting agents, including irrigating 
solutions, having  an ATC code beginning with 
V07AB  Any Any  
Contrast media having  an ATC code beginning 
with V08  Any Any  
Tests for allergic diseases having  an ATC code 
beginning with V04CL  Any Any  
Allergen extracts having  an ATC code beginning 
with V01AA  Any Any  
  EN 3   EN ANNEX II  
List of medicinal products or product categories not subject to prescription that shall 
bear the safety features, referred to in Article 4 5(2) 
 
Name of active substance or 
product category  Pharmaceutical form  Strength  Remarks  
omeprazole  gastro -resistant capsule, 
hard 20 mg   
omeprazole  gastro -resistant capsule, 
hard 40 mg   
  EN 4   EN ANNEX III  
 
Notification to the European Commission of medicinal products not subject to prescription 
judged to be at risk of falsification , pursuant to article 54a(4) of Directive 2001/83/EC  
Member State:  
 Name of competent authority:  
 
Entry 
No Active substance 
(Common Name ) Pharmaceutical 
form  Strength  Anatomical 
Therapeutical 
Chemical 
(ATC) Code  Supporting Evidence  
(please provide evidence of 
one or more incidents of 
falsification in the legal 
supply chain and specify the 
source of the information).   
1      
2      
3      
4      
5      
6      
7      
8      
9      
10      
11      
12      
13      
14      
15      
Note: The number of entries is not binding.   
 EN 5   EN ANNEX IV  
 
Notification to the European Commission of medicinal products judged not to be at risk of 
falsification , pursuant to article 54a(4) of Directive 2001/83/EC  
Member State:  
 Name of competent authority:  
 
Entry 
No Active substance 
(Common Name ) Pharmaceutical 
form  Strength  Anatomical 
Therapeutical 
Chemical 
(ATC) Code  Comments / 
Complementary 
information   
1      
2      
3      
4      
5      
6      
7      
8      
9      
10      
11      
12      
13      
14      
15      
Note: The number of entries is not binding.