Directive 2008/29/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the implementing powers conferred on the Commission
Date: 2008-03-11
Institutions: Council of the European Union, European Parliament
Subjects: European Commission, approximation of laws, legal code, medicine, pharmaceutical legislation, powers of the institutions (EU), public health, single market

20.3.2008

EN

Official Journal of the European Union

L 81/51

DIRECTIVE 2008/29/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 11 March 2008

amending Directive 2001/83/EC on the Community code relating to medicinal products for human
use, as regards the implementing powers conferred on the Commission

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(4)

Having regard to the Treaty
Community, and in particular Article 95 thereof,

establishing the European

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and
Social Committee (1),

Acting in accordance with the procedure
Article 251 of the Treaty (2),

laid down in

(5)

(6)

Whereas:

The Commission should be empowered to adapt certain
provisions and annexes,
to adopt arrangements, prin-
ciples and guidelines, and to lay down specific conditions
of application. Since those measures are of general scope
and are designed to amend non-essential elements of
inter alia, by supplementing it
Directive 2001/83/EC,
with new non-essential elements, they must be adopted
regulatory procedure with
in accordance with the
scrutiny provided for
in Article 5a of Decision
1999/468/EC.

Directive 2001/83/EC should therefore be amended
accordingly.

Since the amendments made to Directive 2001/83/EC by
this Directive are technical
in nature and concern
they do not need to be
committee procedure only,
transposed by the Member States.
is therefore not
necessary to lay down provisions to that effect,

It

(1)

(2)

(3)

Directive 2001/83/EC (3) of the European Parliament and
of the Council provides that certain measures are to be
adopted
Council Decision
1999/468/EC of 28 June 1999 laying down the
procedures for
implementing powers
the exercise of
conferred on the Commission (4).

accordance with

in

the

introduced

Decision 1999/468/EC has been amended by Decision
2006/512/EC, which
regulatory
procedure with scrutiny for the adoption of measures
of general scope and designed to amend non-essential
elements of a basic instrument adopted in accordance
with the procedure referred to in Article 251 of the
Treaty, inter alia, by deleting some of those elements or
by supplementing the instrument with new non-essential
elements.

and

the Council

In accordance with the statement by the European
the Commission (5)
Parliament,
for the regulatory
concerning Decision 2006/512/EC,
procedure with scrutiny to be applicable to instruments
adopted in accordance with the procedure referred to in
Article 251 of the Treaty which are already in force,
those instruments must be adjusted in accordance with
the applicable procedures.

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Amendments

Directive 2001/83/EC is hereby amended as follows:

1.

in Article 14(1), the second subparagraph shall be replaced
by the following:

‘If new scientific evidence so warrants, the Commission
may amend the third indent of
the first subparagraph.
That measure, designed to amend non-essential elements
of this Directive, shall be adopted in accordance with the
in
regulatory
Article 121(2a).’;

procedure with

scrutiny

referred

to

2.

in Article 35(1), the third subparagraph shall be replaced by
the following:

(1) OJ C 161, 13.7.2007, p. 45.
(2) Opinion of the European Parliament of 29 November 2007 (not yet
published in the Official Journal) and Council Decision of 3 March
2008.

(3) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Regu-

lation (EC) No 1394/2007 (OJ L 324, 10.12.2007, p. 121).

(4) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision

2006/512/EC (OJ L 200, 22.7.2006, p. 11).

(5) OJ C 255, 21.10.2006, p. 1.

‘These arrangements shall be adopted by the Commission
in the form of an implementing regulation. 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 121(2a).’;

L 81/52

EN

Official Journal of the European Union

20.3.2008

3.

in Article 46(f), the second paragraph shall be replaced by
the following:

‘This point shall also be applicable to certain excipients, the
list of which as well as the specific conditions of appli-
cation of which shall be established by a Directive
adopted by the Commission. That measure, designed to
amend non-essential elements of this Directive by supple-
menting it, shall be adopted in accordance with the regu-
in
latory
Article 121(2a).’;

procedure with

scrutiny

referred

to

4. Article 46a(2) shall be replaced by the following:

‘2.
The Commission shall be empowered to adapt
paragraph 1 to take account of scientific and technical
progress. That measure, designed to amend non-essential
elements of this Directive, shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in
Article 121(2a).’;

5.

in Article 47, the first paragraph shall be replaced by the
following:

products

for medicinal

‘The principles and guidelines of good manufacturing
practices
in
Article 46(f) shall be adopted in the form of a directive.
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 121(2a).’;

referred

to

6. Article 104(7) shall be replaced by the following:

‘7.
The Commission may amend paragraph 6 in view of
experience gained through its operation. That measure,
this
designed
Directive, shall be adopted in accordance with the regu-
latory
in
Article 121(2a).’;

to amend non-essential

procedure with

elements of

scrutiny

referred

to

7.

in Article 107(2), the fourth subparagraph shall be replaced
by the following:

‘The decision on the final measures concerning the product
shall be adopted in accordance with the management
procedure referred to in Article 121(3).’;

8. Article 108 shall be replaced by the following:

‘Article 108

The Commission shall adopt any amendments which may
be necessary to update provisions of Articles 101 to 107 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
in
Article 121(2a).’;

procedure with

scrutiny

referred

to

9. Article 120 shall be replaced by the following:

‘Article 120

The Commission shall adopt any changes which are
necessary in order to adapt Annex I to take account of
Those measures,
scientific
this
elements of
designed
Directive, shall be adopted in accordance with the regu-
latory
in
Article 121(2a).’;

and
progress.
to amend non-essential

procedure with

technical

scrutiny

referred

to

10. Article 121 shall be amended as follows:

(a)

the following paragraph shall be inserted:

‘2a. Where reference is made to this paragraph,
and Article 7 of Decision
Article 5a(1)
1999/468/EC shall
regard to the
provisions of Article 8 thereof.’;

apply, having

to (4)

(b) paragraph 4 shall be replaced by the following:

The

‘4.
procedure
Committee shall be made public.’

rules

of

of

the

Standing

Article 2

Entry into force

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

Article 3

Addressees

This Directive is addressed to the Member States.

Done at Strasbourg, 11 March 2008.

For the European Parliament
The President

H.-G. PÖTTERING

For the Council
The President
J. LENARČIČ