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Article 10 Due date and deferral of the paymentF1F2

United Kingdom

Original text. Later amendments are not shown.

1.

Fees shall be due on the date of the administrative validation of the relevant application unless specific provisions stipulate otherwise. They shall be payable within 45 days of the date of the notification of the administrative validation to the applicant. They shall be paid in euro.

The annual fee shall be due on the first and each subsequent anniversary of the notification of the marketing authorisation decision. It shall be payable within 45 days of the due date. The annual fee shall relate to the preceding year.

The inspection fee shall be payable within 45 days from the date on which the inspection is carried out.

2.

The payment of the fee for an application for a marketing authorisation of a medicinal product to be used in a human pandemic situation shall be deferred until the pandemic situation is duly recognised, either by the World Health Organisation or by the Community in the framework of Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Communityf1. Such deferral shall not exceed five years.

3.

Where any fee payable under this Regulation remains unpaid at its due date and without prejudice to the Agency’s capacity to institute legal proceedings conferred on it by Article 71 of Regulation (EC) No 726/2004, the Executive Director may decide not to provide the requested services or to suspend all the services and procedures under way until the fee has been paid, including the relevant interest as provided for in Article 86 of Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communitiesf2.

Annotations

Textual amendments

F1

Inserted by Council Regulation (EC) No 2743/98 of 14 December 1998.

F2

Substituted by Council Regulation (EC) No 1905/2005 of 14 November 2005 amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency.

Footnotes

f1

OJ L 268, 3.10.1998, p. 1 . Decision as last amended by Regulation (EC) No 1882/2003 ( OJ L 284, 31.10.2003, p. 1 ).

f2

OJ L 357, 31.12.2002, p. 1 . Regulation as amended by Regulation (EC, Euratom) No 1261/2005 ( OJ L 201, 2.8.2005, p. 3 ).

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)