EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 30.3.2015  
COM(2015) 138 final  
  
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL  
on the exercise of the delegation conferred on the Commission pursuant to Directive 
2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the 
Community code relating to medicinal products for human use and pursuant to 
Regulation (E C) No 726/2004 of the European Parliament and of the Council of 
31 March 2004 laying down Community procedures for the authorisation and 
supervision of medicinal products for human and veterinary use and establishing a 
European Medicines Agency   
 
2 REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL  
on the exercise of the delegation conferred on the Commission pursuant to Directive 
2001/83/EC of the European Parliament and of the Council of 6 November 2001 on 
the Community code relating to medicinal products for human use and pursuant to 
Regulation (EC) No 726/2004 of the E uropean Parliament and of the Council of 
31 March 2004 laying down Community procedures for the authorisation and 
supervision of medicinal products for human and veterinary use and establishing a 
European Medicines Agency  
1. INTRODUCTION  
The EU legal framewor k for medicinal products for human use is intended to ensure a 
high level of public health protection and to help the internal market function effectively. 
Moreover, the measures taken should encourage innovation. The framework works on 
the principle that medicinal products are placed on the market only if granted marketing 
authorisation by the competent authorities.  
The requirements and procedures for authorising the marketing of medicinal products for 
human use, and the rules on continuous supervision of products after they have been 
authorised, are laid down principally in Directive 2001/83/EC1 (‘the Medicinal Product 
Directive’) and Regulation (EC) No 726/20042 (‘the Regulation’). These texts also lay 
down harmonised provisions in related areas such as t he manufacture, wholesale 
distribution and advertising of medicinal products for human use. They cannot properly 
be understood in isolation from one another but must instead be considered together.3 
The Medicinal Product Directive, as amended by Directive 2010/84/EU4 and Directive 
2011/62/EU5, empowers the Commission to adopt delegated acts on post -authorisation 
efficacy studies (Article 22b), the principles of good manufacturing practice for active 
substances (Article 47), criteria to assess the potential falsified character of medicinal 
products transiting through the EU (Article 52b) and safety features for medicinal 
products (Article 54a).  
The Regulation, as amended by Regulation (EU) No 1235/20106, empowers the 
Commission to adopt delegated acts on post -authorisation efficacy studies (Article 10b).  
                                                 
1  Directive 2 001/83/EC of the European Parliament and of the Council of 6 November 2001 on the 
Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p. 67.  
2  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying 
down Community procedures for the authorisation and supervision of medicinal products for human 
and veterinary use and establishing a European Medicines Agency, OJ L 136, 30.4.2004, p. 1.  
3  AG Sharpston in Case C -535/11, Novartis Pharma  v Apozyt , ECLI:EU:C:2013:53, paragraph 47.  
4  Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, 
as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal 
products for human  use, OJ L 348, 31.12.2010, p. 74.  
5  Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending 
Directive 2001/83/EC on the Community code relating to medicinal products for human use, as 
regards the prevention of the entry  into the legal supply chain of falsified medicinal products, 
OJ L 174, 1.7.2011, p.74.  
6  Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 
amending, as regards pharmacovigilance of medicinal products for human  use, Regulation (EC) 
No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal 
 
3 2. LEGAL BASIS  
The present report is a requirement under Article 121a(1) of the Medicinal Product 
Directive and Article 87b(1) of the Regulation. These provisions delegate powers to the 
Commission for five years from January 2011 and require it to report on its exercise of 
those powers at the latest six months before the end of this period.  
3. EXERCISE OF THE DELEG ATION  
During the period the Commission adopted two delegated acts, one on post -authorisation 
efficacy st udies and the other on the principles of good manufacturing practice for active 
substances. In both cases, the exercise of the empowerment responds to the need to 
supplement non -essential elements of a legislative act.  
3.1. Delegated act on post -authorisation efficacy studies  
Under Article 21a(f) of the Medicinal Product Directive and Article 9(4)(cc) of the 
Regulation, it may be necessary in specific situations to complement the data available at 
the time a medicinal product was granted marketing authorisation  with additional 
information on its efficacy, to address concerns that could not be resolved before the 
authorisation was granted. Moreover, under Article  22a(1)(b) of the Directive and Article 
10a(1)(b) of the Regulation, information that becomes availabl e post -authorisation may 
necessitate significant revision of previous efficacy evaluations and call for additional, 
confirmatory efficacy data while the marketing authorisation is maintained. In both 
situations, the national competent authorities, the Euro pean Medicines Agency and the 
Commission may oblige the marketing authorisation holder to conduct a post -
authorisation efficacy study.  
Under Article 22b of the Medicinal Product Directive and Article 10b of the Regulation, 
the Commission is empowered to sp ecify the situations in which post -authorisation 
efficacy studies may be required. The same provisions give the Commission 
discretionary powers in deciding whether to adopt a delegated act. That said, the 
Directive and the Regulation require that any post -authorisation efficacy study imposed 
as an obligation on the marketing authorisation holder ‘shall be based on the delegated 
act’. This implies that a delegated act is a pre -condition for imposing post -authorisation 
efficacy studies. For the application of  the new approach, it was therefore considered 
necessary to adopt a delegated act.  
Moreover, the delegated act increases predictability and transparency regarding situations 
in which post -authorisation studies may be required.  
The Expert Group7 formed by t he Pharmaceutical Committee was consulted on the 
subject of the draft Commission Delegated Regulation. The consultation took place at the 
Expert Group’s meeting of 4 June 2013 on the basis of a Commission working 
document. The Commission adopted the delega ted act on 3 February 2014 and notified 
the European Parliament and the Council of it. Neither institution objected to the 
delegated act within the two -month period provided for in Article 121c of the Directive 
                                                                                                                                                 
products for human and veterinary use and establishing a European Medicines Agency, and Regulation 
(EC) No 1394/2007 on advanced therapy m edicinal products, OJ L 348, 31.12.2010, p. 1.  
7  Expert groups that help the Commission in relation to the preparation of delegated acts are listed in the 
Register of Commission Expert groups: http://ec.europa.eu/transparency/regexpert/.  
 
4 and Article 87d of the Regulation. Commission  Delegated Regulation (EU) No  357/2014 
was published in the Official Journal8 and entered into force on 30  April  2014.  
3.2. Delegated act on good manufacturing practice for active substances  
Directive 2011/62/EU amends the Medicinal Product Directive by introdu cing new 
provisions on the manufacturing of active substances, the active ingredients of medicines. 
These provisions aim to ensure that only active substances that are safe and of high 
quality are used in the manufacturing of medicines in the Union.  
As a r esult of this amendment, since 2 January 2013 the manufacturing of active 
substances has been subject to good manufacturing practice for active substances 
regardless of whether the substances are manufactured in the Union or imported. In 
addition, manufact urers of medicinal products are now obliged to use only active 
substances manufactured in accordance with the principles and guidelines of good 
manufacturing practice for such substances.  
In this context, it is necessary to set EU -wide standards for the ma nufacturing of active 
substances and to harmonise the implementation and enforcement of these standards 
throughout the EU. To this end, Article 47(3) of the Medicinal Product Directive 
mandates the Commission to adopt, by means of delegated acts, measures supplementing 
the provisions of that Directive on good manufacturing practice for active substances.  
To prepare a Commission delegated regulation ‘on the principles and guidelines of good 
manufacturing practice for active substances in medicinal products for human use’, an 
Expert Group ‘on the preparation of delegated acts relating to manufacturing, import and 
introduction of medicinal products for human use and their active substances’ was set up. 
It was consulted on 21 September 2012 and — in writing — in September 2013. The 
Commission adopted the delegated act on 28 May 2014 and notified the European 
Parliament and the Council of it on 17 July 2014. The European Parliament decided to 
extend the deadline for objections until 17 November 2014, in accordanc e with 
Article  121c of the Medicinal Product Directive, but neither it nor the Council issued any 
objections. Commission Delegated Regulation (EU) No 1252/2014 was published in the 
Official Journal9 and entered into force on 15 December 2014.  
3.3. Other delegat ions 
As regards the delegation in Article 54a of the Medicinal Product Directive, the 
Commission intends, before the end of 2015, to adopt a delegated regulation 
supplementing the Directive ‘with regard to the detailed rules for the safety features 
appeari ng on the packaging of medicinal products for human use’.  
To prepare this delegated regulation, the Commission carried out extensive consultations 
with interested parties. An Expert Group on the delegated act on safety features for 
medicinal products for h uman use was set up and met seven times between December 
2011 and January 2015. The Commission met with key European associations 
                                                 
8  Commission Del egated Regulation (EU) No 357/2014 of 3 February 2014 supplementing 
Directive  2001/83/EC of the European Parliament and of the Council as regards situations in which 
post-authorisation efficacy studies may be required, OJ L 107, 10.4.2014, p. 1.  
9  Commiss ion Delegated Regulation (EU) No 1252/2014 of 28 May 2014 supplementing 
Directive  2001/83/EC of the European Parliament and of the Council with regard to principles and 
guidelines of good manufacturing practice for active substances for medicinal products for human use, 
OJ L 337, 25.11.2014, p. 1.  
 
5 representing manufacturers, wholesale distributors and pharmacies in June 2011, 
December 2012, December 2013 and April 2014. I n addition, a public consultation was 
held from 18 November 2011 to 27 April 2012.  
The delegation in Article 52b of the Medicinal Product Directive allows — but does not 
oblige — the Commission to adopt a delegated act clarifying the criteria to be conside red 
and the verifications to be made when assessing the potential falsified character of 
medicinal products introduced into the EU but not intended to be placed on the market. 
To this end, the Commission carried out a public consultation on a concept paper  in 
April  2013. The consultation showed that Member States’ and stakeholders’ interest in 
the proposed measures was limited. Consequently, the Commission does not intend to 
initiate work on a delegated act at this stage.  
4. CONCLUSION  
To date the Commission h as exercised the delegated powers provided for by Regulation 
(EC) No 726/2004 and in two of the four instances provided for by Directive 
2001/83/EC.  
The Commission is of the view that the delegated powers conferred by Articles 22b, 47, 
52b and 54a of Direc tive 2001/83/EC , as amended by Directive 2010/84/EU and 
Directive 2011/62/EU, and by Article 10b of Regulation  (EC) No 726/2004, as amended 
by Regulation (EU) No 1235/2010,  should remain in force.