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Medicine manufacturers obliged to apply these labels on external packaging

What is a control label?

A control label (in Serbian, kontrolna markica) is a rectangular shaped label with the dimensions specified by the Regulation on Content and Manner for Marking External and Internal Packaging of Medicine and on Content of Patient Information Leaflet (2008) (the “Regulation”), which is to be placed on a particular part of the external packaging (the so-called “blue box”) of a medicine. This label contains the following elements:

(1) The words the Republic of Serbia Ministry of Health ALIMS (in the case of human medicines, whereas ALIMS represents an abbreviation for the Agency of Medicines and Medical Devices of Serbia), i.e. the words Republic of Serbia MPŠV (in the case of veterinary medicines, whereas MPŠV represents an abbreviation for the Ministry of Agriculture, Forestry and Water Management, Veterinary Administration);

(2) Serial number of a control label;

(3) Barcode which contains the serial number of the control label;

(4) Hologram with the markings of the competent ministry (in the case of human medicine, it is the Ministry of Health, i.e. in the case of veterinary medicines, it is the Ministry of Agriculture, Forestry and Water Management).

Initial statutory term for use of control labels was 1 August 2009

Under the Regulation, external packaging of each medicine marketed in Serbia has to contain – in addition to the usual required elements (such as the name of the medicine, the active substances, the pharmaceutical form, the name and the seat of the manufacturer and of the marketing authorization holder, the number of the authorization, and other) – certain additional elements. Such additional elements of a medicine‛s external packaging are: (1) the control label, and (2) the additional label.

The term established by the Regulation as a final termfor all the manufacturers of medicines to start using control labels, i.e. to comply with labelling their medicines‛ outer packaging with the rules envisaged by the Regulation, was 1 August 2009.

However, although the stated term has not been changed formally, a full implementation of the respective rules has not been realized within mentioned time frame due to the fact that, in practice, the conditions necessary for realization of this project by competent state authorities have not been met on time.

Current situation on control labels

The current situation with control labels is that a request to receive one (the “Relevant Request”) can be filed with ALIMS. It appears that there is no formal term for filing the Relevant Request, but it should be filed (if it has not been filed yet) as soon as possible, in particular taking into consideration the above-mentioned formally established term for full implementation of the rules on control labels. In any case, the Relevant Request should be filed on a particular form (form ZKM) prescribed by the Regulation.

However, it should be noted that, under the current practice of ALIMS, there is one additional condition to be fulfilled when submitting the Relevant Request. Namely, the applicants for the Relevant Request should have prior approval (also by ALIMS) variation for their medicines and such variation would relate to complying the medicines' outer packaging with the requirements established by the Regulation, as indicated above. It appears that a procedure for obtaining this kind of variation is a standard procedure which is carried out under the general rules for obtaining any other required variation of medicines, in accordance with the relevant Serbian legislation.

If, however, an outer packaging of a medicine has not complied with the requirements established by the Regulation yet, prior to filing the Relevant Request is to file with ALIMS, a request for obtaining its expert opinion on the particular medicine's outer packaging, i.e. a request for approval of the variation (the “Additional Requests”). Nevertheless, there is no need for filing any Additional Requests, if ALIMS has made an evaluation of a particular medicine's outer packaging within the procedure for obtaining a marketing authorization or its renewal, provided that such procedure was initiated on or after April 2008.

In any case, it is important to mention that ALIMS does not issue control labels, but it forwards filed requests to the National Bank of Serbia – Institute for Manufacturing Banknotes and Coins Topčider (the”Institute”) which issues them directly. More precisely, the Regulation provides that the Institute issues control labels directly to a person authorized for taking them over (in the case of local manufacturers of medicines), i.e. delivers them by mail to a foreign manufacturer of particular medicines (in the case of medicines manufactured outside Serbia).

What is an additional label?

As already indicated above, one of the additional elements which, besides a control label, should be included on external packaging of medicines marketed in Serbia, is an additional label (in Serbian, dodatna markica).

Nevertheless, unlike a control label which – on the basis of a filed request and on the condition that the costs of its printing and issuing have been paid – is provided by the state, an additional label is a label provided by the manufacturer or wholesaler, which is placed on the original external packaging of a medicine.

Furthermore, unlike a control label which should always be placed on the outer packaging of every medicine, an additional label should be placed on the outer packaging of a medicine only if (1) it is a medicine the original outer packaging of which contains information on the medicine only in a foreign language, and if it is (2) a medicine registered in Serbia taking into consideration that its annual consumption is less than 5000 packs or it is a medicine which, although not registered in Serbia, is imported for the purpose of treatment of particular patient or group of patients (exceptionally, ALIMS may pass a decision that an additional label does not need to be placed on the outer packaging of such medicine, under the condition that there is an urgent need for its appliance in treating certain patient or group of patients). The content of the additional label is explicitly governed by the Regulation.

Moreover, an additional label should - prior to commencement of its appliance in the above-mentioned sense - be approved by the Agency. In that respect, an application to obtain an expert opinion with respect to the suggested draft of an additional label (the “Draft”), should be filed with ALIMS, together with proof of payment of the administrative fee in the amount of RSD 5,000.00 (approximately EUR 54.00) and the Draft itself. In addition, the following documents should also be submitted to the Agency: (1) information on the quantity of a particular medicine used during the preceding year and the relevant document issued by the Serbian Customs Administration on the basis of which the imported quantity of the medicine can be determined, (2) the annual plan for consumption of the particular medicine, for that calendar year, and (3) a copy of the marketing authorization.

Should you need any additional information or consultation with respect to any of above-mentioned issues or any other issues regarding pharmaceutical law, feel free to contact us on the following e-mail addresses:

Sanja.spasenovic@karanovic-nikolic.com

Dragomir.kojic@karanovic-nikolic.com

Marjan.poljak@karanovic-nikolic.com