Article 8 Various FeesF1F2
United Kingdom
Fee for scientific advice
The scientific advice fee shall apply where an application is made for scientific advice concerning the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products.
When it concerns medicinal products for human use, the fee shall be F3EUR 89 000.
When it concerns veterinary medicinal products, the fee shall be EUR 44 400.
By derogation from the second subparagraph, a reduced scientific advice fee falling within the range of EUR 22 400 to EUR 66 800 shall apply for certain scientific advice concerning medicinal products for human use.
By derogation from the third subparagraph, a reduced scientific advice fee falling within the range of EUR 11 200 to EUR 33 500 shall apply for certain scientific advice concerning veterinary medicinal products.
The scientific advice referred to in the fourth and fifth subparagraph shall be included in a list, which shall be drawn up in accordance with Article 11(2).
2.Fee for scientific services not covered by Articles 3 to 7 or by Article 8(1)
A scientific service fee shall apply where an application is made for any scientific advice or opinion by a scientific Committee, which is not covered by Articles 3 to 7 or by Article 8(1). This includes any evaluation of traditional herbal medicinal products, any opinion on medicinal products for compassionate use, any consultation on ancillary substances, including blood derivatives, incorporated in medical devices, and any evaluation of plasma master files and vaccine antigen master files.
When it concerns medicinal products for human use, the fee shall be EUR 296 500.
When it concerns veterinary medicinal products, the fee shall be EUR 148 400.
Article 3 of this Regulation shall apply to any scientific opinion for the evaluation of medicinal products for human use intended exclusively for markets outside the Community pursuant to Article 58 of Regulation (EC) No 726/2004.
By derogation from the second subparagraph, a reduced scientific service fee falling within the range of EUR 3 300 to EUR 255 500 shall apply for certain scientific opinions or services concerning medicinal products for human use.
By derogation from the third subparagraph, a reduced scientific service fee falling within the range of EUR 3 300 to EUR 127 900 shall apply for certain scientific opinions or services concerning veterinary medicinal products.
The scientific opinions or services referred to in the fifth and sixth subparagraph shall be included in a list, which shall be drawn up in accordance with Article 11(2).
3.Fee for administrative services
A fee falling within the range of EUR 100 to EUR 7 400 shall apply for administrative services where documents or certificates are issued outside the framework of services covered by another fee provided for in this Regulation or where an application is rejected following the conclusion of the administrative validation of the related dossier or where the information required in the case of parallel distribution has to be checked.
A classification of the services and fees shall be included in a list, which shall be drawn up in accordance with Article 11(2).
Annotations
Textual amendments
Notes on the whole EU Regulation
Textual amendments
- F1
Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(b) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)