TITLE XII

STANDING COMMITTEE
Article 120
The Commission shall adopt any changes which are necessary in order to adapt Annex I 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 121(2a).
Article 121
1
The Commission shall be assisted by the Standing Committee on Medicinal Products for Human Use, hereinafter called
‘
the Standing Committee
’
, in the task of adapting to technical progress the directives on the removal of technical barriers to trade in the medicinal products sector.
2
Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
2a
Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
3
Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month.
4
The rules of procedure of the Standing Committee shall be made public.
Article 121a
1
The power to adopt the delegated acts referred to in Article 22b shall be conferred on the Commission for a period of 5 years from
20 January 2011
. The Commission shall draw up a report in respect of the delegated powers not later than 6 months before the end of the 5 year period. The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 121b.
2
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
3
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 121b and 121c.
Article 121b
1
The delegation of powers referred to in Article 22b may be revoked at any time by the European Parliament or by the Council.
2
The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation.
3
The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the
Official Journal of the European Union
.
Article 121c
1
The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification.
At the initiative of the European Parliament or the Council that period shall be extended by 2 months.
2
If, on expiry of the period referred to in paragraph 1, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the
Official Journal of the European Union
and shall enter into force on the date stated therein.
The delegated act may be published in the
Official Journal of the European Union
and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.
3
If either the European Parliament or the Council objects to the delegated act within the period referred to in paragraph 1, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.
Substituted by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Inserted by 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 (Text with EEA relevance).
Substituted by 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.
Inserted by 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.