Paragraph 58 Periodic safety update reports

(1)

The marketing authorisation holder must submit to the Secretary of State records of all adverse reactions (including nil reports) in the form of a periodic safety update report for each marketing authorisation in accordance with this paragraph, including a summary of each incident and a list of all the symptoms using internationally recognised veterinary and medical terminology.

(2)

If the marketing authorisation holder has not yet placed a product on the market in the United Kingdom, he must submit a periodic safety update report immediately upon request of the Secretary of State or at least every six months after authorisation.

(3)

Following the placing on the market in the United Kingdom, the marketing authorisation holder must submit a periodic safety update report to the Secretary of State immediately upon request and —

(a)

at least every six months during the first two years following the initial placing on the market;

(b)

once a year for the following two years; and

(c)

thereafter, at three-yearly intervals.

(4)

Following the granting of a marketing authorisation, the marketing authorisation holder may apply to the Secretary of State to change the periods of notification.

(5)

The periodic safety update report must include a scientific evaluation of the risk benefit balance of the veterinary medicinal product.

(6)

The periodic safety update report must include—

(a)

the volume of the product sold in each year covered by the report, calculated on an annual basis beginning 1st January;

(b)

the number of adverse reactions for each year of the report;

(c)

the ratio of adverse reactions to volume of product sold together with an explanation of the basis of the calculation;

(d)

differentiation of data based on—

(i)

target species (if the product is authorised for use in more than one species);

(ii)

reaction type (such as serious, non-serious, human, suspected lack of efficacy, unauthorised use or other);

(iii)

the country of origin of the report.

(7)

If the product is indicated for more than one species, the information in sub-paragraph (6) must be based so far as is practicable on the estimated use of the product.

(8)

Data relating to different formulations (either different dosage forms or different strengths) must be provided in separate reports.

(9)

It is an offence to fail to comply with this paragraph.