
Article 1 
This Regulation lays down rules on the granting of a marketing authorisation subject to specific obligations in accordance with Article 14(7) of Regulation (EC) No 726/2004, hereinafter ‘conditional marketing authorisation’.
Article 2 
This Regulation shall apply to medicinal products for human use that fall under Article 3(1) and (2) of Regulation (EC) No 726/2004 and belong to one of the following categories:

1.. medicinal products which aim at the treatment, the prevention or the medical diagnosis of seriously debilitating diseases or life-threatening diseases;
2.. medicinal products to be used in emergency situations, in response to public health threats duly recognised either by the World Health Organisation or by the Community in the framework of Decision No 2119/98/EC;
3.. medicinal products designated as orphan medicinal products in accordance with Article 3 of Regulation (EC) No 141/2000.
Article 3 

1. A request for a conditional marketing authorisation may be presented by the applicant together with an application in accordance with Article 6 of Regulation (EC) No 726/2004. The request shall be accompanied by details showing that the product falls within the scope of this Regulation and satisfies the requirements laid down in Article 4(1).The Agency shall immediately inform the Commission of applications containing a request for a conditional marketing authorisation.
2. The Committee for Medicinal Products for Human Use, hereinafter ‘the Committee’, may, in its opinion on an application submitted in accordance with Article 6 of Regulation (EC) No 726/2004, propose a conditional marketing authorisation, after having consulted the applicant.
Article 4 

1. A conditional marketing authorisation may be granted where the Committee finds that, although comprehensive clinical data referring to the safety and efficacy of the medicinal product have not been supplied, all the following requirements are met:
(a) the risk-benefit balance of the medicinal product, as defined in Article 1(28a) of Directive 2001/83/EC, is positive;
(b) it is likely that the applicant will be in a position to provide the comprehensive clinical data;
(c) unmet medical needs will be fulfilled;
(d) the benefit to public health of the immediate availability on the market of the medicinal product concerned outweighs the risk inherent in the fact that additional data are still required.In emergency situations as referred to in Article 2(2), a conditional marketing authorisation may be granted, subject to the requirements set out in points (a) to (d) of this paragraph, also where comprehensive pre-clinical or pharmaceutical data have not been supplied.
2. For the purposes of paragraph 1(c), ‘unmet medical needs’ means a condition for which there exists no satisfactory method of diagnosis, prevention or treatment authorised in the Community or, even if such a method exists, in relation to which the medicinal product concerned will be of major therapeutic advantage to those affected.
Article 5 

1. By way of specific obligations, the holder of a conditional marketing authorisation shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the risk-benefit balance is positive and providing the additional data referred to in Article 4(1).In addition, specific obligations may be imposed in relation to the collection of pharmacovigilance data.
2. The specific obligations referred to in paragraph 1 and the timeframe for their completion shall be clearly specified in the conditional marketing authorisation.
3. The Agency shall make the specific obligations and the timeframe for their completion publicly available.
Article 6 

1. After its period of validity of one year the conditional marketing authorisation may be renewed annually.
2. The application for renewal shall be submitted to the Agency at least six months before the expiry of the conditional marketing authorisation, together with an interim report on the fulfilment of the specific obligations to which it is subject.
3. The Committee shall assess the application for a renewal, on the basis that the risk-benefit balance is to be confirmed, taking into account the specific obligations contained in the authorisation and the timeframe for their fulfilment, and shall formulate an opinion as to whether the specific obligations or their timeframes need to be retained or modified. The Agency shall ensure that the opinion of the Committee is given within 90 days following receipt of a valid renewal application. That opinion shall be made publicly available.
4. Once a renewal application has been submitted in accordance with paragraph 2, the conditional marketing authorisation shall remain valid until a decision is adopted by the Commission in accordance with Article 10 of Regulation (EC) No 726/2004.
Article 7 
Where the specific obligations laid down in accordance with Article 5(1) have been fulfilled, the Committee may at any time adopt an opinion in favour of the granting of a marketing authorisation in accordance with Article 14(1) of Regulation (EC) No 726/2004.
Article 8 
Where a medicinal product has been granted conditional marketing authorisation in accordance with this Regulation, the information included in the summary of product characteristics and package leaflet shall contain a clear mention of that fact. The summary of product characteristics shall also contain the date on which the conditional authorisation is due for renewal.
Article 9 
The periodic safety update reports provided for in Article 24(3) of Regulation (EC) No 726/2004 shall be submitted to the Agency and Member States immediately upon request or at least every six months following the granting or renewal of a conditional marketing authorisation.
Article 10 
A potential applicant for a marketing authorisation may request the advice of the Agency on whether a specific medicinal product being developed for a specific therapeutic indication falls within one of the categories set out in Article 2 and fulfils the requirement laid down in Article 4(1)(c).
Article 11 
The Agency shall develop guidelines concerning the scientific application and the practical arrangements necessary to implement this Regulation. The guidelines shall be adopted after consultation with stakeholders and a favourable opinion of the Commission.
Article 12 
This Regulation shall apply to applications pending at the time of its entry into force.
Article 13 
This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 29 March 2006.
For the Commission
Günter VERHEUGEN
Vice-President