Changes from plenary report to adopted text

Added2. Following the receipt of a valid application in accordance with the provisions of Article 76(2), the Agency shall within 90 days adopt a decision as to whether or not a product-specific waiver shall be granted.

AddedWhenever appropriate, the Agency may request the applicant to supplement the particulars and documents submitted. Where the Agency avails itself of this option, the 90-day time-limit shall be suspended until such time as the supplementary information requested has been provided.

Added3. When appropriate, the Agency may of its own motion adopt decisions, on the basis of the grounds set out in Article 75(1), to the effect that a class or a product-specific waiver, as referred to in Article 75(2), should be granted.

Added4. The Agency may, at any time adopt a decision reviewing an already granted waiver.

Added5. If a particular product-specific or class waiver is revoked, the requirement set out in Article 6(5) of [revised Directive 2001/83/EC] shall not apply for 36 months from the date of its removal from the list of waivers.

Added6. The procedure laid down in Article 87 shall apply for the adoption of decisions by the Agency.

Added7. In consultation with the Commission and with interested parties, the Agency shall draw up and publish guidelines for the practical application of this Article.

AddedArticle 79 List of waivers

AddedThe Agency shall maintain a list of all waivers granted. The list shall be updated regularly and made available to the public.

AddedArticle 80 Waivers granted following a negative decision on a paediatric investigation plan

AddedIf, having considered a paediatric investigation plan, the Agency concludes that Article 75(1), points (a), (b) or (c), applies to the medicinal product concerned, it shall adopt negative a decision under Article 77, paragraphs 1, 2 or 4.

AddedIn such cases, the Agency shall adopt a decision in favour of a waiver under Article 78(3). The two decisions shall be adopted at the same time by the Agency.

AddedThe procedure laid down in Article 87 shall apply for the adoption of decisions by the Agency.

AddedArticle 81 Deferrals

Added1. At the same time as the application for a paediatric investigation plan is submitted under Article 76(1) or during the assessment for a paediatric investigation plan, the applicant may also make a request for deferral of the initiation or completion of some or all of the measures set out in that plan. Such deferral shall be justified on scientific and technical grounds or on grounds related to public health.

AddedIn any event, a deferral shall be granted when it is appropriate to conduct studies in adults prior to initiating studies in the paediatric population or when studies in the paediatric population will take longer to conduct than studies in adults.

Added2. The Agency shall adopt a decision on the request referred to in paragraph 1 and inform the applicant thereof. The Agency shall adopt such decision at the same time as the adoption of the positive decision under Article 77, paragraphs 1 or 2.

AddedA decision in favour of a deferral shall specify the time-limits for initiating or completing the measures concerned.

Added3. The length of the deferral shall be specified in a decision of the Agency and shall be substantiated by scientific and technical grounds or by considerations pertaining to public health and not exceed five years. [Am. 216]

Added4. On the basis of the experience acquired as a result of the operation of this Article, the Commission is empowered to adopt delegated acts in accordance with Article 175 to amend the grounds for granting a deferral referred to in paragraph 1.

AddedArticle 82 Prolongation of deferrals

Added1. In duly justified cases, a request for a prolongation of the deferral, may be submitted, at least 6 months before the expiry of the deferral period. A prolongation of the derogation shall not exceed the duration of the deferral period given under Article 81(3).

AddedThe Agency shall decide on the prolongation within 60 days.

Added2. Whenever appropriate, the Agency may ask the applicant to submit additional particulars and documents, in which case the time-limit of 60 days shall be suspended until the supplementary information requested has been provided.

Added3. The procedure laid down in Article 87 shall apply for the adoption of decisions by the Agency.

AddedArticle 83 Waivers during a public health emergency

Added1. The decision by the Agency referred to in Article 6(5), point (e) of [revised Directive 2001/83/EC] shall concern only medicinal products intended for the treatment, prevention or medical diagnosis of a serious or life-threatening disease or condition which are directly related to the public health emergency.

Added2. The decision mentioned under paragraph 1 shall include the grounds for providing such derogation and its duration.

Added3. At the latest at the date of expiry of the derogation referred to in paragraph 2, the applicant shall submit to the Agency a paediatric investigation plan or an application for a waiver with a request for agreement in accordance with the provisions of Article 76(1).

AddedArticle 84 Modification of a paediatric investigation plan

Added1. If, following the decision agreeing the paediatric investigation plan, the applicant encounters such difficulties with its implementation as to render the plan unworkable or no longer appropriate, the applicant may propose changes or request the Agency to issue a deferral in accordance with Article 81 or a waiver in accordance with Article 75. The Agency shall adopt within 90 days a decision on the basis of the procedure laid down in Article 87. When appropriate, the Agency may request the applicant to supplement the particulars and documents submitted. Where the Agency avails itself of this option, the time-limit shall be suspended until such time as the supplementary information requested has been provided.

Added1a. The procedure provided for in paragraph 1 of this Article shall also apply when the applicant updates the elements of an initial paediatric investigation plan submitted in accordance with Article 74(2). [Am. 217]

Added2. If, following the decision agreeing the paediatric investigation plan referred to in Article 77, paragraphs 1, 2 and 4, or on the basis of the updated paediatric investigation plan received in accordance with Article 77(3), the Agency, on the base of new scientific information available, considers that the agreed plan or any of its elements are no longer appropriate, it shall request, based on detailed scientific grounds, that the applicant to propose changes to the paediatric investigation plan. [Am. 218]

AddedThe applicant shall submit the changes requested within 60 days.

AddedWithin 30 days, the Agency shall review these changes and adopt a decision on their refusal or acceptance.

Added2a. Within the timelines for adoption of a decision provided for in Articles 77, 78, 80, 81, 82 and 84, the Agency shall transmit its scientific conclusions to the applicant. [Am. 219]

Added2b. Where marketing authorisation applicants or marketing authorisation holders disagree with the scientific conclusions, they may respond within 20 days of receipt of those conclusions by providing detailed grounds and evidence for re-examination.

AddedThe Agency shall assess the request for re-examination and may request more information from the marketing authorisation applicant or marketing authorisation holder in this process.

AddedWithin 30 days of receipt of a request for re-examination, the Agency shall confirm its scientific conclusions or commence a re-examination where deemed justified. [Am. 220]

Added3. Within the time period referred to in paragraph 2, third subparagraph, the Agency may request the applicant for additional modifications to the submitted changes or to submit additional information, in those cases the time-limits referred to in paragraph 2, third subparagraph, shall be extended by another 30 days. This time-limit shall be suspended until the supplementary information requested or the additional modifications have been provided.

Added4. The procedure laid down in Article 87 shall apply for the adoption of decisions by the Agency.

AddedArticle 85 Detailed arrangements for applications in relation to paediatric investigation plans, waivers and deferrals

Added1. In consultation with the Member States, the Commission and interested parties, the Agency shall draw up the detailed arrangements concerning the format and content which applications for agreement or modification of a paediatric investigation plan, and requests for waivers or deferrals are to follow in order to be considered valid and concerning the operation of the compliance check referred to in Articles 48, 49(2), 86 and 90(2) of [revised Directive 2001/83/EC].

Added2. The detailed arrangement concerning the format and content of applications for agreement of a paediatric investigation plan mentioned in paragraph 1 shall:

Added(a) specify which information should be included in an application for agreement or modification of a paediatric investigation plan or requests for a waiver in the cases referred to in Article 75(1);

Added(b) be adapted to take into account the specificities of:

Added(i) adapted procedure for paediatric investigation plans as referred to in Article 74(2);

Added(ii) products intended to be developed only for use in children;

Added(iii) products intended to be submitted under the procedure referred to in Article 92.

AddedArticle 86 Compliance with the paediatric investigation plan

AddedWhere the application is submitted in accordance with the procedures set out in in this Regulation, the Committee for Medicinal Products for Human Use shall verify whether an application for marketing authorisation or variation complies with the requirements laid down in Article 6(5) of [revised Directive 2001/83/EC].

AddedArticle 87 Procedure for adopting a decision in relation to paediatric investigation plans, a waiver or a deferral

Added1. Decisions referred to in Articles 77, 78, 80, 81, 82 and 84 adopted by the Agency shall be supported by scientific conclusions which shall be annexed to the decision.

Added2. Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when preparing the above mentioned scientific conclusions. The outcome of such consultations shall be annexed to the decision.

Added3. Decisions of the Agency shall be made public after deletion of any information of a commercially confidential nature.

AddedArticle 88 Discontinuation of a paediatric investigation plan

AddedWhere a paediatric investigation plan, agreed in accordance with the provisions of Article 77, paragraphs 1, 2 and 4, is discontinued, the applicant shall notify the Agency of its intention to discontinue the conduct of the paediatric investigation plan and provide the reasons for such discontinuation no less than six months before the discontinuation or as soon as possible. [Am. 221]

AddedThe Agency shall publish this information.

AddedArticle 89 Scientific advice for paediatric developments

AddedAny legal or natural person developing a medicinal product intended for paediatric use or intended for in utero treatment may, prior to the submission of a paediatric investigation plan and during its implementation, request advice from the Agency on the design and conduct of the various tests and studies necessary to demonstrate the quality, safety and efficacy of the medicinal product in the paediatric population in accordance with Article 138(1), point (za).