Published: 2012-07-21
Key Benefits:
Passed 16.07.2012 Annex 26
The Regulation is established under § 785 section 14 of the Medicinal Products Act.
With the present Regulation, the procedure for providing safety information about a medicinal product and the calculation of fee payable for safety and quality surveillance of a medicinal products is established.
(1) A doctor, dentist, veterinarian, nurse, midwife or user of a medicinal product shall inform the State Agency of Medicines of a suspected adverse reaction of a medicinal product, using the electronic form of a suspected adverse reaction report or a paper report.
(2) The electronic form of a suspected adverse reaction report is available on the web page of the State Agency of Medicines and the paper form in the State Agency of Medicines and pharmacies. If necessary, the dispensing chemist or pharmacist shall help a user of a medicinal product to complete the suspected adverse reaction report of a medicinal product and submit it to the State Agency of Medicines.
(3) When reporting a suspected adverse reaction, at least the following information shall be submitted:
1) details of the person having submitted the information (name, e-mail address, telephone, position and institution); if the information is submitted by a user of the medicinal product assisted by a dispensing chemist or pharmacist, both the details of the user of the medicinal product and the details of the dispensing chemist or pharmacist;
2) details of the user of the medicinal product (initials, sex, birth date or age), in the event of a veterinary medicinal product the identification information of the treated animal(s) or animal group(s), sex and age of the animal(s);
3) medicinal product associated with the suspected adverse reactions (name, active ingredient, lot number, strength, pharmaceutical form);
4) description of the suspected adverse reaction(s).
(4) The State Agency of Medicines or the marketing authorisation holder submits information regarding a serious suspected adverse reaction to the Eudravigilance database within 15 days and regarding a non-serious suspected adverse reaction within 90 days from the date of receiving the information. In the event of a veterinary medicinal product, the marketing authorisation holder submits information regarding a serious suspected adverse reaction to the State Agency of Medicines or the Eudravigilance database within 15 days from receiving the information.
(5) In the event of a medicinal product with marketing authorisation issued in Estonia, the holder of marketing authorisation submits information into the Eudravigilance database in regard to suspected adverse reactions detected in Estonia, other member states and third countries, reported by a user of the medicinal product or a person authorised to prescribe the medicinal product, or discovered during a safety survey following the receipt of a marketing authorisation, or published in medical scientific publications, if the source indicated is not in the list monitored by the European Medicines Agency. In the event of a veterinary medicinal product, the holder of marketing authorisation submits information to the State Agency of Medicines about suspected adverse reactions detected in Estonia and to the Eudravigilance database about suspected adverse reactions detected in third countries, reported by a user of the medicinal product or a person authorised to prescribe the medicinal product, or discovered during a safety survey following the receipt of a marketing authorisation, or published in medical scientific publications, if the source indicated is not in the list monitored by the European Medicines Agency.
(1) Periodic safety update shall be drafted according to Directive No. 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, pages 67–128) or Directive No. 2001/82/EC of the European Parliament and of the Council on the Community code relating veterinary medicinal products (OJ L 311, 28.11.2001, pages 1–66) and according to good pharmacovigilance practice.
(2) The frequency of submitting a periodic safety update is specified in the terms of marketing authorisation of the medicinal product. Generally, the marketing authorisation holder submits a safety update from the date of receiving the marketing authorisation as follows:
1) every six months until the commencement of marketing of a medicinal product;
2) every six months during the first two years after the commencement of marketing;
3) once a year during the two years following the period provided in clause 2;
4) once every three years after the period provided in clause 3;
5) immediately upon a relevant request of the State Agency of Medicines.
(3) The beginning of calculation of the terms provided in section 2 of the present paragraph may be a date assigned by the pharmacovigilance risk evaluation committee of the European Medicines Agency, time of granting the first marketing authorisation for the same active ingredient or combination of active ingredients in a member state of the European Economic Area, or the time of granting the marketing authorisation in a third country under a written authorisation of the European Medicines Agency.
(4) The periodical safety report shall cover the time period from the end of the first reporting period and it shall be submitted within 60 days from completing the collection of information, considering the terms provided in sections 2 and 3 of the present paragraph.
(1) Informing persons authorised to prescribe the medicinal product in the event of risk includes information provided to such persons to ensure safe and effective use of the medicinal product, if the ratio of benefit and risks of the medicinal product has changed in negative direction.
(2) Persons authorised to prescribe the medicinal product may be informed of a negative change in the ratio of benefit and risks of the medicinal product by the marketing authorisation holder or the State Agency of Medicines. If the information concerns a medicinal product of more than one marketing authorisation holder, the relevant marketing authorisation holders shall draft the information text together.
(3) Before the submission of information to persons authorised to prescribe the medicinal product the marketing authorisation holder shall have the information text and plan of submission of the information approved by the State Agency of Medicines.
(4) The plan of providing information shall include the following:
1) the time schedule of distributing the information;
2) a list of the target group;
3) description of the method of distributing the information;
4) contact details of a representative (Estonian-speaking) of the marketing authorisation holder in Estonia;
5) if necessary, additional materials to be distributed to persons authorised to prescribe the medicinal product.
(5) The information text shall include the following:
"The State Agency of Medicines or the marketing authorisation holder shall be informed of all suspected adverse reactions that have occurred.
State Agency of Medicines: use the form for reporting a suspected adverse reaction of a medicinal product (available at address: http://www.ravimiamet.ee).
<Name of the holder of marketing authorisation>: <contact details>."
(6) The information must not be misleading or include characteristics of advertisement of a medicinal product.
(7) The State Agency of Medicines shall inform the marketing authorisation holder of the approval of the text and plan of distribution of the information, a need for introducing changes or refusal from approval within five working days from the date of receiving the text and distribution plan of the information.
(1) A marketing authorisation holder pays the fee for safety and quality surveillance of a medicinal product by March 1st of every year according to an invoice issued by the State Agency of Medicines.
(2) The State Agency issues an invoice for safety and quality surveillance by February 1st of the calendar year following the year for which the fee is calculated.
(3) The State Agency of Medicines shall have a right to exempt the marketing authorisation holder from the payment obligation of safety and quality surveillance fee based on a relevant justified application of the marketing authorisation holder, if:
1) the medicinal product has not been marketed in Estonia in the relevant period, or
2) the wholesale of the medicinal product has remained under 4,800 euros and 2,000 packages.
(4) An application for exemption from the fee for safety and quality surveillance of a medicinal product shall be submitted to the State Agency of Medicines latest by February 25th.
The regulation shall enter into force on July 21st, 2012.
11Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, pages 1–66), amended by Directives 2004/28/EC (OJ L 136, 30.04.2004, pages 58–84), 2009/9/EC (OJ L 44, 14.02.2009, pages 10–61) and 2009/53/EC (OJ L 168, 30.06. 2009, pages 33–34); Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, pages 67–128), amended by Directives 2002/98/EC (OJ L 033, 08.02.2003, pages 30–40), 2003/63/EC (OJ L 159, 27.06.2003, pages 46–94), 2004/24/EC (OJ L 136, 27.06.2003, pages 85–90), 2004/27/EC (OJ L 136, 30.04.2004, pages 34–57), 2008/29/EC (OJ L 81, 20.03.2008, pages 51–52), 2009/53/EC (OJ L 168, 30.06.2009, pages 33–34), 2009/120/EC (OJ L 242, 15.09.2009, pages 3–12) and 2010/84/EU (OJ L 348, 31.12.2010, pages 74–99).
