Marketing authorisation

Time frame

How long does it take, in general, to obtain an authorisation from application to grant, what fees are payable and what is the normal period of validity of the authorisation?

ALIMS conducts a formal review of an application for marketing authorisation within 30 days. The deadline for the substantive review is 210 days, which is paused from the day of request of additional documents from the applicant, until submission of those documents. The accelerated procedure for obtaining a marketing authorisation takes 150 days from receipt of a complete application, for a medicinal product that obtained a marketing authorisation in accordance with the EU centralised procedure, and for medicines for human use of utmost importance for public healthcare.

Marketing authorisation is valid for five years. It may be renewed based on the reassessment of the risk-benefit ratio of the medicine. If ALIMS determines that a medicine is safe (based on the available pharmacovigilance data), it grants a permanent marketing authorisation.

The fee for marketing authorisation for a medicinal product on the basis of complete documentation for pharmaceutical form, strength and package of the medicine is 460,000 Serbian dinar. Additional fees are payable for each additional pharmaceutical form (240,000 Serbian dinar), each additional strength of the same pharmaceutical form (150,000 Serbian dinar), each type of additional inner package of the same pharmaceutical form and strength (30,000 Serbian dinar), and each additional package size (30,000 Serbian dinar). The same fees apply for issuing a conditional marketing authorisation, marketing authorisation under exceptional circumstances and a temporary marketing authorisation. Reduced fees apply for issuance of a marketing authorisation based on reduced documentation.

Protecting research data

What protection or exclusivities apply to the data submitted by originators to gain initial approval and, on variation or new application, to add indications or pharmaceutical forms?

The exclusivity period for the data submitted by originators to obtain the marketing authorisation is 10 years from the issuance of the initial marketing authorisation. Amendments to the marketing authorisation in terms of medicinal product strength, pharmaceutical form, methods of administration, packaging or variations and claims for extension of the scope of the marketing authorisation, do not extend the exclusivity period.

An applicant for a marketing authorisation issuance with reduced documentation (for a generic medicinal product, generic hybrid medicinal product or biologically similar medicinal product) may apply for marketing authorisation after at least eight years have elapsed from the date the initial marketing authorisation for the reference medicinal product had been issued in Serbia, the European Union or countries that have the same or similar requirements for the issuance of the authorisation, and may obtain a marketing authorisation after 10 years from the date of issuance of the initial marketing authorisation.

The period of 10 years may be extended (cumulatively) for one more year, if, during the eight years from the issuance of the marketing authorisation for the reference medicinal product, the marketing authorisation holder (MAH) of the reference medicinal product obtains a new marketing authorisation for one or more new indications that show a significant improvement in the therapeutic indication of the reference medicinal product.

Freedom of information

To what extent and when can third parties make freedom of information applications for copies of research data submitted by applicants for authorisation to market medicinal products or medical devices?

The Serbian Freedom of Information Act of 2004 (as amended) provides that public authorities must not allow access to information in its possession when a law considers such information as classified.

The MMDA provides that all the data in the documentation enclosed within a marketing authorisation application, as well as in other procedures carried out before the ALIMS or competent ministries, must be treated as classified.

Public authorities may make classified information available to third parties with the consent of the applicant in a procedure before ALIMS. Data available to the expert and general public for the purpose of providing the information necessary for the use or handling of a medicinal product, or required for the protection of health in humans and animals, may not be considered classified.

Regulation of specific medicinal products

Are there specific rules for approval, and rewards or incentives for approval, of particular types of medicinal products, such as traditional herbal and homeopathic products, biologicals and biosimilars, controlled drugs, orphan drugs and those for paediatric use?

Marketing authorisation is not required for traditional herbal medicines or homeopathic medicines. The ALIMS keeps special registries for these types of medicines. There are no specific rules for approval, and rewards or incentives for approval, for biologicals and biosimilars, controlled drugs, orphan drugs or drugs for paediatric use.

Post-marketing surveillance of safety

What pharmacovigilance or device vigilance obligations apply to the holder of a relevant authorisation once the product is placed on the market?

In the post-marketing phase, MAHs are obligated to:

  • organise continued monitoring of adverse drug reactions (ADRs) and have a permanently employed person with adequate qualifica­tions responsible for pharmacovigilance;
  • keep records on all suspected ADRs notified in Serbia, EU countries or any third country, and provide ALIMS with electronic reports;
  • keep records of all suspected serious ADRs reported by health or veterinary professionals, or records of ADRs that MAHs can reasonably be expected to be aware of, and to promptly report this information to the ALIMS no later than 15 days following the receipt of information;
  • submit to the ALIMS periodic drug safety reports in six-month intervals if the marketing authorisation was conditional or under special circumstances; and
  • submit periodic drug safety reports every six months for a period of two years following the placing of the medicine on the mar­ket, then annual reports for another two years and finally submit reports in three-year intervals.

For medical devices, a manufacturer or its authorised represen­tative must employ a person responsible for vigilance and continuously monitor the medical device on the market with the aim of identifying any need for corrective or preventive measures. The designated person keeps records of any measures taken and informs ALIMS accordingly.

The manufacturer or its authorised representative must also inform the notified or appointed body that carried out the conformity assessment of any changes in the system of vigilance that affect the conformity assessment. In the case of incidents, the manufacturer or its authorised representative must, without delay, inform ALIMS of any initiated field safety corrective action taken to reduce the risk of death or serious deterioration of health related to the medical device.

Other authorisations

What authorisations are required to manufacture, import, export or conduct wholesale distribution and storage of medicinal products and medical devices? What type of information needs to be provided to the authorities with an application, what are the fees, and what is the normal period of validity?

A licence is required for the manufacturing of medicines and the Ministry may issue these to legal entities only. The applicants for manufacturing must accompany the application with information and documents regarding their location and premises, equipment, personnel, medicines to be produced and relevant procedures, as well as other information required by the MMDA and the relevant rulebook. The fee payable for the manufacturing licence is 79,550 Serbian dinar and the licence is valid for an indefinite period.

A licence to manufacture medical devices may be issued to a legal entity or an individual. The Ministry issues manufacturing licences for class I medical devices (other than Is and Im class), other in vitro diagnostic medical devices, medical devices for which no conformity assessment is performed, those not covered by the sign of conformity, custom-made devices for a particular patient and medical devices for clinical trials, as well as systems or kits. The applicant must support its application with information and documents regarding the location and premises, equipment, personnel, medical devices to be produced and relevant procedures, as well as other information required by the MDA. The fee payable for the manufacturing licence is 79,550 Serbian dinar and the licence is valid for five years.

Wholesale of medicines and medical devices encompasses purchase, storage, distribution, imports and exports of medicines. A wholesale licence issued by the Ministry is required to perform wholesale. Exceptionally, manufacturers may distribute medicines or medical devices that they manufacture without a wholesale licence. However, manufacturers of medical devices with a registered seat in Serbia that do not need a manufacturing licence must obtain a wholesale licence to sell their medical devices. Legal entities performing only import or export activities on behalf of and for the account of a medicines wholesale licence holder do not have the obligation to obtain a wholesale licence. Applicants for wholesale licences for medicines and medical devices must support their applications with information and documents regarding the legal entity, location and premises, supply territory, products for which the wholesale licence is sought, personnel, equipment and plan for an urgent withdrawal of products from the market, as well as other information of relevance for issuance of the wholesale licence.

The Ministry issues wholesale licences for medicines for an indefinite period, and for medical devices for a period of five years. The fees for both, payable to the Ministry, amount to 39,780 Serbian dinar.

Sanctions

What civil, administrative or criminal sanctions can authorities impose on entities or their directors and officers for breach of the requirements concerning controlled activities?

Placement on the market, manufacturing or trade of medicines contrary to the rules imposed under the MMDA constitute a commercial offence for which a fine ranging from 1.5 to 3 million Serbian dinar may be imposed. Conformity assessment, manufacturing, trade, labelling, presentation, conduct of vigilance or advertising of medical devices contrary to the MDA constitute a commercial offence and a fine ranging from 1.5 million to 3 million Serbian dinar may be made against a legal entity, while a fine ranging from 300,000 to 500,000 Serbian dinar may be imposed on an individual as a manufacturer of medical devices. Furthermore, performance of the relevant business activity for the legal entity manufacturing medicines or medical devices may be forbidden for three to 10 years, and for the individual manufacturer of medical devices, from six months to three years.

Exemptions

What, if any, manufacture and supply of medicinal products is exempt from the requirement to obtain an approval to market?

Marketing of magistral and galenic medicines, traditional herbal and homeopathic medicines (unless otherwise stipulated in the MMDA), as well as other products and substances enlisted under article 39 of the MMDA, is exempt from the obligation to obtain a marketing authorisation.

Parallel trade

Are imports allowed into your jurisdiction of finished products already authorised in another jurisdiction, without the importer having to provide the full particulars normally required to obtain an authorisation to market? What are the requirements?

Parallel trade of medicines is not allowed in Serbia. The Trademarks Act of 2009 (as amended) provides for a principle of national exhaustion of rights, which means that a trademark entitles its holder to prohibit its use on the goods that were not placed on the market in Serbia by the trademark holder or another person authorised by the holder.