Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the terms of marketing authorisations for medicinal products {SEC(2008)273} {SEC(2008)274}
Date: 2008-03-04
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 4.3.2008 
COM(2008) 123 final 

2008/0045 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the 
terms of marketing authorisations for medicinal products 

(presented by the Commission) 

{SEC(2008)273} 
{SEC(2008)274} 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

1.1. 

Grounds for and objectives of the proposal 

Within  the  European  Community,  medicinal  products  are  regulated  throughout  their  entire 
lifetime. Changes subsequent to their placing on the market, such as change in the production 
process, change in the packaging or change in the address of the manufacturer, are governed 
either  by  national  provisions  or  by  Community  rules:  Commission  Regulations  (EC)  Nos 
1084/2003  and  1085/20031  (hereinafter  referred  to  as  the  "Variations  Regulations").  This 
framework applies to medicines for both human and veterinary use. 

The  Variations  Regulations  are  implementing  measures  adopted  by  'comitology'  regulatory 
procedure.  The  legal  bases  for  these  implementing  measures  are  laid  down  in  Article  39  of 
Directive  2001/82/EC2,  Article  35  of  Directive  2001/83/EC3  and  Articles  16  and  41  of 
Regulation  (EC)  No  726/20044.  Those  legal  bases  limit  the  scope  of  the  Variations 
Regulations to the following medicinal products: 

–  medicinal  products  which  have  been  granted  a  Community  (‘centralised’)  marketing 

authorisation in accordance with Regulation (EC) No 726/2004; 

–  medicinal products which have been granted a marketing authorisation in accordance with 
the  provisions  of  Chapter  4  of  Directive  2001/83/EC  or  Directive  2001/82/EC  ('mutual 
recognition' and 'decentralised' procedure); 

–  medicinal  products  which  have  been  considered  within  the  scope  of  application  of 

Directive 87/22/EEC5 (so called 'ex-concertation' medicinal products). 

However,  the  current  Variations  Regulations  do  not  apply  to  changes  to  marketing 
authorisations  for  medicinal  products  which  have  been  granted  at  a  national  level  by  a 
Member  State  competent  authority  under  a  national  procedure  and  which  do  not  fall  within 
the above categories (hereinafter referred to as 'purely national' marketing authorisations). In 
the  absence  of  Community  harmonisation,  changes  affecting  purely  national  authorisations 
are  therefore  subject  to  national  rules.  In  some  Member  States,  national  requirements  on 
changes to purely national authorisations nevertheless follow the Variations Regulations, by 
analogy.  But  in  the  majority  of  Member  States  there  is  no  such  alignment  on  Community 
legislation, which results in discrepancies between the rules of those Member States. 

The objective of this proposal is therefore to amend Directives 2001/82/EC and 2001/83/EC 
in  order  to  empower  the  Commission  to  extend  the  scope  of  the  corresponding  Variations 
Regulation,  namely  Regulation  (EC)  No  1084/2003.  This  would  ensure  that  all  medicinal 
products, regardless of the procedure under which they have been authorised, are subject to 
the same criteria for the evaluation, approval and administrative treatment of variations. This 

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5 

OJ L 159, 27.6.2003, p.1 and OJ L 159, 27.6.2003, p. 24 respectively. 
OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, 
p. 58). 
OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1394/2007 (OJ L 324, 
10.12.2007, p. 121). 
OJ L 136, 30.4.2004, p. 1. Regulation as last amended by Regulation (EC) No 1394/2007 (OJ L 324, 
10.12.2007, p. 121). 
Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of 
high-technology  medicinal  products,  particularly  those  derived  from  biotechnology,  OJ  L  15, 
17.1.1987, p. 38. 

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proposal is part of the Commission Legislative and Work Programme for 2008, under Annex 
2  (simplification  initiatives)6.  It  is  also  part  of  a  broader  'Better  Regulation'  initiative  to 
review  the  content  of  the  Variations  Regulations  in  order  to  make  the  framework  simpler, 
clearer and more flexible, without compromising public and animal health7. 

1.2. 

General context 

Purely  national  marketing  authorisations  represent  the  vast  majority  of  authorisations  in  the 
European  Community  (more  than  80%),  both  in  the  human  and  in  the  veterinary  sector. 
Although purely national authorisations, like any other marketing authorisation for medicinal 
products  within  the  European  Community,  are  granted  in  accordance  with  the  harmonised 
requirements  laid  down  in  Directive  2001/82/EC  and  Directive  2001/83/EC,  changes  to 
purely national authorisations are at present not subject to harmonised Community rules. For 
example, critical changes such as the introduction of a new therapeutic indication, or of a new 
method  of  administration,  may  be  treated  differently  in  the  Member  States  as  regards 
regulatory  classification,  administrative  procedures,  timelines  and  scientific  criteria  for  the 
assessment of changes. 

This situation has negative consequences in terms of public health, administrative burden and 
overall functioning of the internal market in pharmaceuticals. 

From  a  public  health  perspective,  there  appears  to  be  no  justification  for  Member  States 
applying different scientific criteria for evaluating changes to medicinal products. 

From a legal perspective, it does not seem justified that the requirements for the granting of 
the initial marketing authorisation are fully harmonised at Community level, whereas the post-
authorisation requirements are not. 

From  a  practical  perspective,  the  current  situation  increases  the  administrative  and  financial 
burden for both pharmaceutical companies and Member States competent authorities: 

–  Undertakings,  which  very  often  operate  globally  but  on  the  basis  of  purely  national 
authorisations,  may  be  confronted  with  different  rules  in  different  Member  States.  This 
legal  uncertainty  may  delay,  impair  or  even  prevent  the  introduction  of  certain  changes, 
including changes which may benefit patients by improving the safety/efficacy profile of 
the  concerned  product(s).  It  also  raises  logistical  issues  for  the  actual  implementation  of 
changes; 

–  Member States competent authorities must follow different legal requirements, depending 

on whether they are dealing with changes to a purely national authorisation or not. 

Finally, discrepancies amongst Member States as regards purely national variations may also 
affect  the  functioning  of  the  internal  market,  by  hindering  the  free  movement  of  medicinal 
products  initially  authorised  at  a  purely  national  level  but  subsequently  undergoing  mutual 
recognition. 

1.3. 

Existing provisions in the area of the proposal 

The  proposal  amends  the  two  main  pieces  of  Community  legislation  in  the  area  of 
pharmaceuticals, namely: 

–  Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 

on the Community code relating to veterinary medicinal products; 

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http://ec.europa.eu/atwork/programmes/docs/clwp2008_en.pdf (see page 32) 
http://ec.europa.eu/enterprise/pharmaceuticals/varreg/index.htm

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–  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. 

Those  two  legislative  acts,  together  with  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, lay down harmonised rules for the authorisation, 
supervision and pharmacovigilance of medicinal products within the Community. 

1.4. 

Consistency with the other policies and objectives of the Union 

The  proposal  is  consistent  with  the  overall  objective  of  the  Community  pharmaceutical 
legislation, which is to remove disparities between national provisions in order to ensure the 
proper  functioning  of  the  internal  market  for  medicinal  products,  while  at  the  same  time 
safeguarding a high level of protection of public, human and animal health. The proposal also 
complies  with  Article  152(1)  of  the  Treaty  establishing  the  European  Community,  which 
provides  that  a  high  level  of  human  health  protection  shall  be  ensured  in  the  definition  and 
implementation of all Community policies and activities. 

2. 

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

2.1. 

Consultation of interested parties 

Consultation methods, main sectors targeted and general profile of respondents

All interested parties, in particular patients associations, Member States competent authorities 
and  industry  associations,  have  been  widely  consulted  on  this  proposal.  Various  means  of 
consultation have been used, namely internet-based public consultation, dedicated workshops, 
questionnaires and bilateral meetings. In particular: 

–  a  targeted  consultation  was  conducted  in  October  2006-January  2007  with  industry 
associations and Member States competent authorities, on the basis of an ‘Issue paper’; 

–  a  public  consultation  was  conducted  in  July-September  2007,  on  the  basis  of  a  draft 

proposal. 

The detailed results of the public consultation process, including a summary of the outcome, 
are  available  on  http://ec.europa.eu/enterprise/pharmaceuticals/varreg/index.htm.  Additional 
details  on  the  consultations  conducted  by  the  Commission  can  be  found  in  the  Impact 
Assessment attached to this proposal. 

Summary of responses and how they have been taken into account

The  Impact  Assessment  attached  to  this  proposal  contains  a  summary  of  all  the  responses 
received and explains how those responses have been taken into account by the Commission 
when preparing this proposal. 

2.2. 

Impact assessment 

The  details  of  the  impact  assessment  are  provided  in  the  Commission  Staff  Working 
Document 'Impact Assessment' attached to this proposal. 

Several  policy  options  have  been  considered  by  the  Commission  when  preparing  this 
proposal. The 'status quo' option (i.e. no change to the scope of application of the Community 
Variations  Regulations)  would  leave  the  situation  as  it  is  today  and  would  not  address  the 
harmonisation issue faced both by industry and by Member States competent authorities. The 
issue  is  all  the  more  important  as  purely  national  authorisations  are  the  vast  majority  of 
authorisations, both in the human and veterinary sector. 

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A  'partial  harmonisation'  option  was  envisaged,  whereby  only  the  technical  requirements 
would  be  harmonised,  while  procedural  aspects  such  as  the  timelines  for  evaluation  of 
changes would remain subject to specific national rules. However, this would not address the 
main  practical  issue  for  economic  operators,  which  is  precisely  related  to  the  logistical 
complications  that  disharmonised  procedures  across  various  Member  States  can  entail  (e.g. 
different timelines for evaluation of changes). 

A 'full harmonisation, no transitional period' option was envisaged. This option would readily 
address the harmonisation issue. However, it was recognised that a number of Member States 
competent authorities and companies have been working under national, sometimes diverging 
frameworks for many years already, and are actually used to these frameworks. Any proposal 
to  modify  the  scope  of  the  Regulation  (EC)  No  1084/2003  and  to  bring  changes  to  purely 
national authorisations within this scope should therefore take into account the workload that 
such a regulatory 'shift' would entail for stakeholders. For this reason, a 'full harmonisation, 
with a period of transition' option appeared preferable. 

It is important to note that since this legal proposal only concerns the legal base empowering 
the  Commission  to  act  at  'comitology'  level,  the  abovementioned  transitional  period  will  be 
introduced  only  once  the  subsequent  'comitology'  modification  of  the  scope  of  Regulation 
(EC) No 1084/2003 is adopted. The transitional period will be introduced through a delay of 
application of this subsequent 'comitology' modification. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

3.1. 

Summary of the proposed action 

The proposal is of purely legal nature. It only modifies the legal basis of Regulation (EC) No 
1084/2003,  thereby  empowering  the  Commission  to  modify  subsequently  the  scope  of  that 
Regulation by 'comitology' procedure. Enlarging the scope of Regulation (EC) No 1084/2003 
will  ensure  that  all  medicinal  products  placed  on  the  Community  market  -including  those 
authorised  at  purely  national  level  -  are  subject  to  the  same  criteria  for  the  approval  and 
administrative handling of changes, regardless of the procedure under which those medicines 
have been authorised. 

3.2. 

Legal basis 

The  proposal  is  based  on  Article  95  of  the  Treaty,  which  provides  for  the  use  of  the  'co-
decision' procedure referred to in Article 251 of the Treaty. Article 95 is the main legal basis 
of  the  whole  Community  pharmaceutical  legislation,  including  Directive  2001/83/EC  and 
Directive 2001/82/EC which this proposal seeks to amend. 

3.3. 

Subsidiarity principle 

The  subsidiarity  principle  applies  insofar  as  the  proposal  does  not  fall  under  the  exclusive 
competence of the Community. 

The proposal seeks to harmonise an area where, by definition, action of Member States alone 
is not sufficient to bring full harmonisation and currently leads to divergent approaches for the 
evaluation and supervision of changes to medicinal products. Action by Member States alone 
is therefore not expected to be sufficient to bring full harmonisation in this area. This issue is 
important from a quantitative point of view, since purely national authorisations are the vast 
majority of marketing authorisations within the Community. 

Community action appears to be the most efficient way to achieve a genuine harmonisation 
and  to  ensure  that  all  authorised  medicinal  products  are  subject  to  the  same  criteria  for  the 

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approval,  administrative  treatment  and  supervision  of  changes,  regardless  of  the  legal 
procedure under which those medicinal products have been authorised. 

It is important to note that most of the purely national authorisations are related to relatively 
‘old’  products  which  have  often  been  authorised  before  the  ‘centralised’  authorisation 
procedure  was  established  (1995),  but  which  are  actually  authorised  in  a  large  number  of 
Community Member States (one product=one authorisation in Germany, one authorisation in 
Poland, one in Italy etc.). As a result, changes to these products simultaneously affect a large 
number of marketing authorisations in several Member States. The administrative burden and 
logistical  complications  caused  by  the  current  lack  of  harmonisation  of  the  rules  governing 
these changes are hence very high for industry operators. 

It  should  also  be  borne  in  mind  that  the  current  situation  also  increases  the  administrative 
burden for Member States competent authorities, who have to apply different rules depending 
on whether they deal with a purely national authorisation, a mutual recognition procedure or a 
centralised authorisation. As a result, resources of the regulators (and the industry, see above 
paragraph) are being diverted away from public health protection. 

Finally,  the  feedback  gathered  during  the  consultation  phase  demonstrates  that  the  vast 
majority of stakeholders, including the authorities of Member States where a national system 
is in place, support harmonisation in this field. 

3.4. 

Proportionality principle 

The proposal has been carefully designed with all stakeholders, in order to avoid imposing an 
unnecessary regulatory burden. The proposal does not go beyond what is necessary to achieve 
the objective pursued, i.e. harmonisation of requirements for the evaluation and supervision of 
changes to medicinal products. 

3.5. 

Choice of instruments 

The  proposal  aims  at  laying  down  a  proper  legal  basis  for  the  examination,  approval  and 
supervision of variations to the terms of marketing authorisations for all medicinal products. 
Since  the  proposal  amends  two  existing  Directives,  a  Directive  is  considered  as  the  most 
appropriate legal instrument. 

4. 

BUDGETARY IMPLICATION 

The proposal has no implication for the Community budget. 

5. 

ADDITIONAL INFORMATION 

5.1. 

Simplification 

This project is referenced in the Commission Agenda Planning as 2008/ENTR/016. It is part 
of the Commission Legislative and Work Programme for 2008, under Annex 2 (simplification 
initiatives)8. 

This  proposal  is  intended  to  allow  the  simplification  of  legislation  and  of  administrative 
procedures for public authorities and private parties, as it provides the Commission with the 
power to modify the scope of Regulation (EC) No 1084/2003. 

The  proposal  is  expected  to  simplify  legislation  by  allowing  harmonisation,  so  that  all 
operators within the European Community are subject to the same rules for the evaluation and 

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http://ec.europa.eu/atwork/programmes/docs/clwp2008_en.pdf (see page 32) 

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supervision  of  changes  to  medicinal  products,  thereby  eliminating  diverging,  redundant  or 
contradicting requirements. 

The  proposal  is  expected  to  simplify  the  administrative  procedures  for  Member  States 
competent  authorities  by  allowing  harmonisation  of  the  requirements  for  evaluation  and 
supervision  of  all  changes  to  all  medicinal  products.  Thus,  competent  authorities  will  no 
longer have to follow different requirements depending on the legal status of the product. 

The  proposal  is  expected  to  simplify  the  administrative  procedures  for  private  parties,  as 
companies,  which  very  often  operate  globally  but  on  the  basis  of  purely  national 
authorisations, will no longer be confronted with different rules in different Member States. 

5.2. 

European Economic Area 

The  proposed  act  concerns  an  EEA  matter  and  should  therefore  extend  to  the  European 
Economic Area. 

5.3. 

Note on comitology 

Decision 1999/468/EC laying down the procedures for the exercise of implementing powers 
conferred  on  the  Commission  has  been  amended  by  Decision  2006/512/EC9,  which 
introduces  the  regulatory  procedure  with  scrutiny.  This  procedure  is  applicable  to 
implementing measures of general scope intended to amend non-essential elements of a basic 
instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty 
(i.e. ‘co-decision’), including by deleting some of those elements or by supplementing them 
by the addition of new non-essential elements. 

As  regards  Directive  2001/83/EC,  a  Commission  proposal  amending  this  Directive  and 
introducing the regulatory procedure with scrutiny  for a number of implementing measures, 
including Article 35 of Directive 2001/83/EC concerning variations, has recently been agreed 
by  the  European  Parliament  and  the  Council10.  For  reasons  of  consistency,  the  regulatory 
procedure with scrutiny should therefore be kept in the amendments to Directive 2001/83/EC 
which this proposal lays down. 

As  regards  Directive  2001/82/EC,  a  Commission  proposal  amending  this  Directive  and 
introducing the regulatory procedure with scrutiny  for a number of implementing measures, 
including  Article  39  of  Directive  2001/82/EC  concerning  variations,  has  recently  been 
adopted  by  the  Commission.  For  reasons  of  legal  consistency,  the  amendments  to  Directive 
2001/82/EC  laid  down  in  the  referred  Commission  proposal  should  be  outlined  in  this 
proposal as well. 

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OJ L 200, 22.7.2006, p. 11. 
COM(2006)0919 – C6-0030/2007 – 2006/0295(COD) 

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2008/0045 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  

amending Directive 2001/82/EC and Directive 2001/83/EC as regards variations to the 
terms of marketing authorisations for medicinal products 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
95 thereof, 
Having regard to the proposal from the Commission1, 
Having regard to the opinion of the European Economic and Social Committee2, 
Having regard to the opinion of the Committee of the Regions3, 
Acting in accordance with the procedure laid down in Article 251 of the Treaty4, 

Whereas: 

(1) 

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 
2001  on  the  Community  code  relating  to  veterinary  medicinal  products5,  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  use6  and  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 
Agency7,  lay  down  harmonised  rules  for  the  authorisation,  supervision  and 
pharmacovigilance of medicinal products within the Community. 

(2) 

Under  those  rules,  marketing  authorisations  may  be  granted  in  accordance  with 
harmonised Community procedures. The terms of those marketing authorisations may 
subsequently  be  varied  where,  for  instance,  the  production  process  or  the  address  of 
the manufacturer has changed. 

(3) 

Article 39 of Directive 2001/82/EC and Article 35 of Directive 2001/83/EC empower 
the  Commission  to  adopt  an  implementing  Regulation  as  regards  variations 

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7 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, 
p. 58). 
OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1394/2007 (OJ L 324, 
10.12.2007, p. 121). 
OJ L 136, 30.4.2004, p. 1. Regulation as last amended by Regulation (EC) No 1394/2007 (OJ L 324, 
10.12.2007, p. 121). 

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subsequently  made  to  marketing  authorisations  granted  in  accordance  with  the 
provisions of Chapter 4 of Title III of Directive 2001/82/EC and Chapter 4 of Title III 
of Directive 2001/83/EC, respectively. The Commission therefore adopted Regulation 
(EC)  No  1084/2003  of  3  June  2003  concerning  the  examination  of  variations  to  the 
terms  of  a  marketing  authorisation  for  medicinal  products  for  human  use  and 
veterinary medicinal products granted by a competent authority of a Member State8. 

However, the majority of medicinal products for human or veterinary use currently on 
the  market  have  been  authorised  under  purely  national  procedures  and,  as  such,  fall 
outside  the  scope  of  Regulation  (EC)  No  1084/2003.  Variations  to  marketing 
authorisations  granted  under  purely  national  procedures  are  thus  subject  to  national 
rules. 

It  results  therefrom  that  while  the  granting  of  all  marketing  authorisations  for 
medicinal  products  is  subject  to  harmonised  rules  within  the  Community,  this  is  not 
the case for variations to the terms of marketing authorisations. 

For  reasons  of  public  health,  legal  consistency  and  predictability  for  economic 
operators,  variations  to  all  types  of  marketing  authorisations  should  be  subject  to 
harmonised rules.  

As  regards  Directive  2001/82/EC  power  should  be  conferred  on  the  Commission  in 
particular to adapt certain provisions and annexes, and to lay down specific conditions 
of application. Since those measures are of general scope and are designed to amend 
non-essential elements of that Directive and/or to supplement it by the addition of new 
non-essential  elements,  they  must  be  adopted  in  accordance  with  the  regulatory 
procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. 

(4) 

(5) 

(6) 

(7) 

(8) 

Directive  2001/82/EC  and  Directive  2001/83/EC  should  therefore  be  amended 
accordingly, 

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Amendments to Directive 2001/82/EC 

Directive 2001/82/EC is amended as follows: 

(1) 

Article 10(3) is replaced by the following: 

“3.  By way of derogation from Article 11, the Commission shall establish a list of 
substances essential for the treatment of equidae and for which the withdrawal period 
shall be not less than six months according to the control mechanisms laid down in 
Decisions 93/623/EEC and 2000/68/EC. 

This  measure,  designed  to  amend  non-essential  elements  of  this  Directive,  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 89(2a).” 

(2) 

In Article 11(2), the third subparagraph is replaced by the following: 

“However,  the  Commission  may  modify  these  specific  withdrawal  periods.  Those 
measures,  designed  to  amend  non-essential  elements  of  this  Directive,  shall  be 

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OJ L 159, 27.6.2003, p. 1. 

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adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 89(2a).” 

(3) 

In Article 13(1), the fourth subparagraph is replaced by the following: 

“However,  the  ten-year  period  provided  for  in  the  second  subparagraph  shall  be 
extended to 13 years in the case of veterinary medicinal products for fish or bees or 
other species designated by the Commission. 

That  measure  designed  to  amend  non-essential  elements  of  this  Directive,  by 
supplementing it, shall be adopted in accordance with the regulatory procedure with 
scrutiny referred to in Article 89(2a).” 

(4) 

In Article 17(1), the second subparagraph is replaced by the following: 

“If it appears justified in the light of new scientific evidence, the Commission may 
adapt  points  (b)  and  (c)  of  the  first  subparagraph.  Those  measures,  designed  to 
amend non-essential elements of this Directive, shall be adopted in accordance with 
the regulatory procedure with scrutiny referred to in Article 89(2a).” 

(5) 

The following Article 27b is inserted: 

"Article 27b 

The  Commission  shall  adopt  appropriate  arrangements  for  the  examination  of 
variations  to  the  terms  of  marketing  authorisations  granted  in  accordance  with  this 
Directive.  

The  Commission  shall  adopt  these  arrangements  in  the  form  of  an  implementing 
regulation.  That  regulation,  measure  designed  to  amend  non-essential  elements  of 
this  Directive,  by  supplementing  it,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 89(2a)."  

(6) 

(7) 

In Article 39(1), the second and third subparagraphs are deleted. 

Article 50a (2) is replaced by the following: 

“2.  The  Commission  shall  adopt  any  amendments  which  may  be  necessary  to 
adapt  the  provisions  of  Paragraph  1  to  take  account  of  scientific  and  technical 
progress. 

Those measures, designed to amend non-essential elements of this directive, shall be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 89(2a).” 

(8) 

In Article 51, the first subparagraph is replaced by the following: 

“The  principles  and  guidelines  of  good  manufacturing  practice  for  veterinary 
medicinal products referred to in Article 50(f) shall be adopted by the Commission in 
the form of a Directive addressed to the Member States. Those measures, designed to 
amend non-essential elements of this Directive, by supplementing it, shall be adopted 
in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in  Article 
89(2a).” 

(9) 

In Article 67, point (aa) is replaced by the following: 

“(aa) veterinary medicinal products for food-producing animals. 

However, Member States may grant exemptions from this requirement according to 
criteria established by the Commission. The establishment of those criteria, measure 
designed  to  amend  non-essential  elements  of  this  Directive,  by  supplementing  it, 

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shall be adopted in accordance with the regulatory procedure with scrutiny referred 
to in Article 89(2a). 

Member States may continue to apply national provisions until either: 

– 

– 

the  date  of  application  of  the  decision  adopted  in  accordance  with  the 
first subparagraph; or 

1 January 2007, if no such decision has been adopted by 31 December 
2006;” 

(10)  Article 68(3) is replaced by the following: 

“3.  The Commission shall adopt any amendments to the list of substances referred 
to in paragraph 1. 

Those measures, designed to amend non-essential elements of this Directive, shall be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 89(2a).” 

(11)  Article 75(6) is replaced by the following: 

“6.  The Commission may amend paragraph 5 in the light of the experience gained 
from its operation.  

Those measures, designed to amend non-essential elements of this Directive, shall be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 89(2a).” 

(12)  Article 79 is replaced by the following: 

“Article 79 

The  Commission  shall  adopt  any  amendments  which  may  be  necessary  to  update 
Articles 72 to 78 to take account of scientific and technical progress. 

Those measures, designed to amend non-essential elements of this Directive, shall be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 89(2a).” 

(13)  Article 88 is replaced by the following: 

“Article 88 

The  Commission  shall  adopt  any  changes  which  are  necessary  in  order  to  adapt 
Annex I to take account of technical progress. 

Those measures, designed to amend non-essential elements of this Directive, shall be 
adopted  in  accordance  with  the  regulatory  procedure  with  scrutiny  referred  to  in 
Article 89(2a).” 

(14)  Article 89 is amended as follows: 

(a)  The following paragraph 2a is inserted: 

“2a.  Where  reference  is  made  to  this  paragraph,  Article  5a  (1)  to  (4)  and 
Article 7 of Decision No 1999/468/EC shall apply, having regard to the 
provisions of Article 8 thereof”.  

(b)  Paragraph 4 is replaced by the following: 

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“4.  The rules of procedure of the Standing Committee shall be made public.” 

Article 2 

Amendments to Directive 2001/83/EC 

Directive 2001/83/EC is amended as follows: 

(1) 

The following Article 23b is inserted: 

"Article 23b 

The  Commission  shall  adopt  appropriate  arrangements  for  the  examination  of 
variations  to  the  terms  of  marketing  authorisations  granted  in  accordance  with  this 
Directive.  

These  arrangements  shall  be  adopted  by  the  Commission  in  the  form  of  an 
implementing regulation. This measure, designed to amend non-essential elements of 
this  Directive,  by  supplementing  it,  shall  be  adopted  in  accordance  with  the 
regulatory procedure with scrutiny referred to in Article 121(2a)." 

(2) 

In Article 35(1), the second and third subparagraphs are deleted. 

Article 3 

Transposition 

1. 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 
provisions  necessary  to  comply  with  this  Directive  by  [12  months  after  entry  into 
force] at the latest. They shall forthwith communicate to the Commission the text of 
those provisions and a correlation table between those provisions and this Directive. 

When  Member  States  adopt  those  provisions,  they  shall  contain  a  reference  to  this 
Directive  or  be  accompanied  by  such  a  reference  on  the  occasion  of  their  official 
publication. Member States shall determine how such reference is to be made. 

2. 

Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 

This Directive shall enter into force on the [twentieth] day following that of its publication in 
the Official Journal of the European Union. 

Article 4 

This Directive is addressed to the Member States. 

Done at Brussels, […] 

Article 5 

For the European Parliament 
The President 
[…] 

For the Council 
The President 
[…] 

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