1.

Consultation for a medical device that has not yet been certified

EURO

a.

New substances/Known substances with new applications
New substances are substances that at the time of the request for consultation were not yet included as active ingredients in any medicinal product authorised in the Netherlands.
Known substances on the other hand are substances that at the time of the request for consultation were included as active ingredients in one or more medicinal products authorised in the Netherlands. If the indication to which the consultation procedure relates concerns a therapeutic area different from the indications for which the aforementioned medicinal products are authorised, then this is regarded as a new application of a known substance.

If a request for consultation concerns a series of products, the MEB may decide to levy the amount due only once. The Notified Body should submit a request with supporting arguments for this (see Consultation request form).

12.000

b.

Known substances
See above for a description of known substances.

If a request for consultation concerns a series of products, the MEB may decide to levy the amount due only once. The Notified Body should submit a request with supporting arguments for this (see Consultation request form).

3.600

2.

Consultation on variations
Variations are changes relating to the quality, safety or usefulness of the substance which is an integral component of the medical device but which is a medicinal product when used separately, and where a consultation with a competent authority has already taken place with regard to this substance, which resulted in the product’s certification.

The following changes are excluded from this because they are so far-reaching that the product must be assessed as a new medical device (see 1a. or 1b.):

variations relating to the incorporated substance
- addition of one or more incorporated substances;
- removal of one or more incorporated substances;
- quantitative change in the incorporated substance;
- replacement of the incorporated substance by a different salt / ester complex / derivative;
- replacement by a different isomer, a different combination of isomers or replacement of a combination by an isolated isomer (for instance, replacement of a racemate by a single enantiomer);
- replacement of a biological/biotechnologically prepared substance by a substance with a different molecular structure; or a substance for which a modification of a vector used to prepare the antigen/source material (including a master cell bank from a different source) has been carried out;
- a new ligand or bonding mechanism of a radiopharmacon.

variations relating to the application of the medical device
- addition of an indication in another therapeutic area;
- change to an indication in another therapeutic area;
- addition of a new route of administration;
- change in the route of administration.

variations relating to the medical device
- change that alters the pattern and extent of local and systemic release of the medicinal product.

If no new substance is added in connection with these variations, then the fee as indicated for known substances will be applied. If a new substance is added, then the fee to be applied will depend on whether the substance added is a new substance or a known substance.

1.200