PDCO Opinion Annex I and II - European Medicines Agency



EMA/157468/2019 "Error*"EMA/157468/2019 \* MERGEFORMAT EMA/157468/2019

Annex I

The subset(s) of the paediatric population and condition(s) covered by the waiver and the measures and timelines of the agreed paediatric investigation plan (PIP)

Delete this part only for refusal for initial applications (not for modification refusal)

Waiver

- Delete if there is at least one waiver.

Condition:

Repeat if several conditions.

Condition(s) subject of the ‘full’ or ‘partial’ waiver. This section is to be duplicated per condition.

Make sure that each condition from section 1 is inserted either here or under section 3 or both (covered by a waiver or by a PIP or by a combination of them).

For granting waiver:

The waiver applies to:

For refusing waiver:

The request for the waiver applied to:

• / / ;

Delete or modify as appropriate (and please use always identical wording “from… to less than…”).

Merge continuous age subsets e.g., “The paediatric population from birth to less than 6 years of age”.

• , ;

Copy/paste the form(s) and route(s) as in the cover page of the opinion.

For granted waiver:

The following reason may apply only in exceptional cases, please check if other reasons apply such as listed above.

Choose and delete as appropriate.

In general there should be only one major ground. Different reasons could apply where different paediatric subsets do not share the same ground (e.g., does not occur in neonates and is unsafe in adolescents).

For refused waiver:

The waiver request does not provide evidence to support the following grounds set out in Article 11(1) of Regulation (EC) No 1901/2006 that:

•

•

•

Because:

• ................
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