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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 (Text with EEA relevance)
10 versions
· 2004-03-31
2022-01-28
Regulation (EC) No 726/2004 of the European Parliament and of the Counc
2019-03-30
Regulation (EC) No 726/2004 of the European Parliament and of the Counc
2019-01-28
Regulation (EC) No 726/2004 of the European Parliament and of the Counc
2013-06-05
Regulation (EC) No 726/2004 of the European Parliament and of the Counc
2012-12-04
Regulation (EC) No 726/2004 of the European Parliament and of the Counc
2012-07-02
Regulation (EC) No 726/2004 of the European Parliament and of the Counc
2009-07-06
Regulation (EC) No 726/2004 of the European Parliament and of the Counc
2009-04-20
Regulation (EC) No 726/2004 of the European Parliament and of the Counc
2008-12-30
Regulation (EC) No 726/2004 of the European Parliament and of the Counc
Changes on 2008-12-30
@@ -280,7 +280,7 @@
#### Article 13
1. Without prejudice to Article 4(4) of Directive 2001/83/EC, a marketing authorisation which has been granted in accordance with this Regulation shall be valid throughout the Community. It shall confer the same rights and obligations in each of the Member States as a marketing authorisation granted by that Member State in accordance with Article 6 of Directive 2001/83/EC.
1. Without prejudice to Article 4(4) and (5) of Directive 2001/83/EC, a marketing authorisation which has been granted in accordance with this Regulation shall be valid throughout the Community. It shall confer the same rights and obligations in each of the Member States as a marketing authorisation granted by that Member State in accordance with Article 6 of Directive 2001/83/EC.
Authorised medicinal products for human use shall be entered in the Community Register of Medicinal Products and shall be given a number, which shall appear on the packaging.
@@ -842,6 +842,8 @@
(d)the Committee on Herbal Medicinal Products;
(da)the Committee for Advanced Therapies;
(e)the Paediatric Committee;
(f)a Secretariat, which shall provide technical, scientific and administrative support for the committees and ensure appropriate coordination between them;
@@ -850,7 +852,7 @@
(h)a Management Board, which shall exercise the responsibilities set out in Articles 65, 66 and 67.
2. The committees referred to in paragraph 1(a) to (d) may each establish standing and temporary working parties. The committees referred to in paragraph 1(a) and (b) may establish scientific advisory groups in connection with the evaluation of specific types of medicinal products or treatments, to which the committee concerned may delegate certain tasks associated with drawing up the scientific opinions referred to in Articles 5 and 30.
2. The committees referred to in paragraph paragraph 1(a) to (da) may each establish standing and temporary working parties. The committees referred to in paragraph paragraph 1(a) and (b) may establish scientific advisory groups in connection with the evaluation of specific types of medicinal products or treatments, to which the committee concerned may delegate certain tasks associated with drawing up the scientific opinions referred to in Articles 5 and 30.
When establishing working parties and scientific advisory groups, the committees shall in their rules of procedures referred to in Article 61(8) provide for:
@@ -1182,7 +1184,7 @@
#### Article 73a
Decisions taken by the Agency under Regulation (EC) No 1901/2006 may form the subject of an action before the Court of Justice of the European Communities under the conditions laid down in Article 230 of the Treaty..
Decisions taken by the Agency under Regulation (EC) No 1901/2006 may form the subject of an action before the Court of Justice of the European Communities under the conditions laid down in Article 230 of the Treaty.
#### Article 74
@@ -1316,6 +1318,8 @@
—recombinant DNA technology,
—controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells,
—hybridoma and monoclonal antibody methods.
1a. Advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products (<sup>25</sup>)
2. Medicinal products for veterinary use intended primarily for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals.
@@ -1324,10 +1328,9 @@
—cancer,
—neurodegenerative disorder,
—diabetes,
and with effect from 20 May 2008
—auto-immune diseases and other immune dysfunctions,
—viral diseases.
After 20 May 2008, the Commission, having consulted the Agency, may present any appropriate proposal modifying this point and the Council shall take a decision on that proposal by qualified majority.
After 20 May 2008, the Commission, having consulted the Agency, may present any appropriate proposal to amend this point and the European Parliament and the Council shall take a decision thereon in accordance with the Treaty.
4. Medicinal products that are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000.
@@ -1378,3 +1381,5 @@
(<sup>23</sup>) OJ L 145, 31.5.2001, p. 43.
(<sup>24</sup>) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
(<sup>25</sup>) OJ L 324, 10.12.2007, p. 121.
2007-01-26
Regulation (EC) No 726/2004 of the European Parliament and of the Co
original version
Text at this date