Paragraph 41 Transitional provision in relation to applications made to EMA before IP completion day under the Paediatric RegulationF1
Where a paediatric investigation plan has been agreed by the EMA in accordance with the Paediatric Regulation before IP completion day, that plan, including any modifications agreed by the EMA before IP completion day, has effect on and after IP completion day as an agreed paediatric investigation plan.
Sub-paragraph (3) applies where—
a paediatric investigation plan has been submitted to the EMA with a request for agreement before IP completion day;
the proposed paediatric plan is valid in accordance with the provisions of Article 15(2) of the Paediatric Regulation; but
the EMA has not adopted a decision to agree the plan before IP completion day.
Where this sub-paragraph applies, the licensing authority must—
where an opinion favourable to agreeing the paediatric investigation plan has been given by the Paediatric Committee before IP completion day, treat the plan as an agreed paediatric investigation plan;
where an opinion against agreeing the paediatric investigation plan has been given by the Paediatric Committee before IP completion day, decide that it cannot agree the plan under regulation 50B(5) (agreement and modification of paediatric investigation plan); or
where before IP completion day no opinion in relation to the paediatric investigation plan has been given by the Paediatric Committee treat it as a request for agreement under regulation 50B(1) and determine that request as soon as reasonably practicable, unless the applicant notifies the licensing authority in writing that they do not want the application to proceed as a request for agreement of a paediatric investigation plan under these Regulations.
Sub-paragraph (5) applies where—
a paediatric investigation plan has been agreed by the EMA in accordance with the Paediatric Regulation before IP completion day;
the person to whom the EMA's decision to agree the plan was addressed has, before IP completion day, made a proposal under Article 22 of the Paediatric Regulation to modify the plan, or to request a waiver; but
the EMA has not adopted a decision to agree to the modification or waiver before IP completion day.
Where this sub-paragraph applies, the licensing authority must—
where an opinion favourable to agreeing the modification or waiver has been given by the Paediatric Committee before IP completion day, agree to the modification or waiver as if it had been requested under regulation 50B(6);
where an opinion against agreeing the modification or waiver has been given by the Paediatric Committee before IP completion day, decide that it cannot agree to the modification or waiver as if it had been requested under regulation 50B(6); or
where before IP completion day no opinion in relation to the modification or waiver has been given by the Paediatric Committee treat the proposal as one made under regulation 50B(6) and consider it accordingly, unless the applicant notifies the licensing authority in writing that they do not want the proposal to proceed as a proposal under regulation 50B(6).
Where the EMA has adopted a decision to grant, and has not revoked, a waiver of the obligation to produce the information in Article 7(1)(a) of the Paediatric Regulation before IP completion day, that waiver has effect on and after IP completion day as a waiver granted by the licensing authority under regulation 50D (waiver of production of information in a paediatric investigation plan).
Sub-paragraph (8) applies where—
an application has been made to the EMA for a waiver of the obligation to produce the information in Article 7(1)(a) of the Paediatric Regulation before IP completion day;
the application has been accepted as valid by the EMA; but
the EMA has not adopted a decision to grant the waiver before IP completion day.
Where this sub-paragraph applies, the licensing authority must—
where an opinion favourable to agreeing the waiver has been given by the Paediatric Committee before IP completion day, grant the waiver under regulation 50D(2);
where an opinion against agreeing the waiver has been given by the Paediatric Committee before IP completion day, decide that it cannot grant the waiver under regulation 50D(2); or
where before IP completion day no opinion in relation to the waiver has been given by the Paediatric Committee treat the proposal as one made under regulation 50D and consider it accordingly, unless the applicant notifies the licensing authority in writing that they do not want the proposal to proceed as a proposal under regulation 50D.
Annotations
Textual amendments
- F1
Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 2020 c. 1, Sch. 5 para. 1(1)