The marketing authorisation holder (MAH) must inform the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) of any deviations from the terms of the marketing authorisation (MA), which do not relate to different labelling of the medicinal product, by submitting a notification of a case of inadequate quality of the medicinal product on the Suspected or Inadequate Quality of the Medicinal Product Form to the following e-mail address: quality-defects@jazmp.si.
If the JAZMP, in its assessment of the inadequate quality of the medicinal product, finds that a deviation from the terms of the MA can be granted, or if the medicinal product has not yet been placed on the market and the holder of the MA is temporarily unable to provide a medicinal product that is in full compliance with the MA, the MAH may, for individual batch or smaller number of batches of the individual medicinal product in exceptional cases which are in the interest of protecting the public health, in accordance to the Article 22 of Medicinal Products Act (Off. Gaz. of RS No. 17/14 and 66/19) submit an application to the JAZMP for the approval of an individual deviation from the terms of the MA which does not affect the quality, safety and efficacy of the medicinal product. A deviation from the terms of a MA does not concern batches of medicinal products which do not comply with the approved specifications of the medicinal product, except in exceptional circumstances of non-critical deviations with adequate justification.
The application may relate to minor and non-critical deviations from the terms of the MA which do not affect the quality, safety and efficacy of the medicinal product, such as:
– the packaging of the medicinal product or the package leaflet in a language other than that approved in the MA (in one of the languages of the Member States of the European Union in the Latin alphabet);
– a different name of the medicinal product from that approved in the Republic of Slovenia;
– minor, therapeutically insignificant differences in the packaging or the package leaflet or failure to implement the variation of the MA within the time limit authorised by the variation in question;
– other minor, non-critical differences from the terms of the MA.
In its application MAH must provide information on the proposed scope of the approval measure of individual deviation, evidence that the deviation does not affect the quality, safety and efficiency of the medicinal product, and a proposal of preventive and correctional measures implemented to establish the supply of the medicinal product within the conditions of the marketing authorisation.
REQUIREMENTS FOR INDIVIDUAL CASES OF DEVIATION FROM THE TERMS OF THE MA
- Different packaging language and package leaflet
If the deviation from the terms of the MA relates to the packaging or package leaflet in a language other than that approved in the MA, namely one of the languages of the Member States of the European Union in the Latin alphabet, and a complete exemption from the requirement for labelling and package leaflet in the Slovene language is proposed in the case of medicinal products which are not intended for direct dispensing to patients in pharmacies, or medicinal products where there are serious problems of availability (e.g. orphan medicinal products), the application must (in addition to general application documentation) also include the following:
– a declaration that the medicinal product complies with the MA in the Republic of Slovenia, except for the language of the packaging and the package leaflet of the medicinal product;
– a declaration that the MAH will provide to the users of the medicinal product administered by healthcare professionals (prescribing and dispensing regimes H and ZZ) the instructions in the Slovene language or refer them in writing to the official website with the approved product information in the Slovene language; for medicinal products intended for dispensing in pharmacies (prescribing and dispensing regimes H/Rp, Rp/Spec and Rp), ensure that the package leaflet in the Slovene language is available in electronic form and are supplied to the patient in printed form at the time of dispensing.
- Other packaging language and package leaflet – re-labelling
If the deviation from the terms of the MA relates to the packaging or package leaflet in a language other than that approved in the MA, namely one of the languages of the Member States of the European Union in the Latin alphabet, and it is proposed to provide the foreign packaging with a label and package leaflet in the Slovene language, the application must (in addition to general application documentation) also include the following:
– a declaration by the MAH that the medicinal product, with its packaging in one of the languages of the Member States of the European Union, corresponds to the MA in the Republic of Slovenia, with the exception of the language of the packaging and the package leaflet;
– the name and address of the business entity which will carry out the activity of providing the foreign packaging with labels and package leaflet in the Slovene language.
The MAH must have in accordance with the regulations, established a system of obligations and responsibilities of the business entities involved in providing the labels and package leaflet in the Slovene language to the medicinal products in foreign packaging and the release of batches.
- Different language of the packaging, the package leaflet and the name of the medicinal product – re-labelling
If the deviation from the terms of the MA relates to packaging or package leaflet in a language other than that approved in the MA, and it also relates to a different name of the medicinal product, the label and the package leaflet must also bear an appropriate warning regarding the name of the medicinal product, e.g. ‘WARNING: The name of medicinal product XY in the Republic of Slovenia is ZW. It is the same medicinal product’. In addition to the information listed in point 2, the MAH must submit a declaration at the application that he/she will inform the Healthcare professionals of a different name of the medicinal product than that approved in the Republic of Slovenia.
- Minor, therapeutically insignificant differences on the packaging or in the package leaflet, or failure to implement the variation of the MA within the time limit approved for the variation in question.
If the deviation from the terms of the MA relates to minor, therapeutically insignificant differences on the packaging or in the package leaflet or to the failure to implement the variation of the MA within the time limit approved for the concerned variation, the application must (in addition to general application documentation) also include:
– the approved mock ups of the packaging or package leaflet and a proposal of a temporary packaging or package leaflet, with the highlighted differences;
– in the case of re-labelling with labels and/or package leaflet:
– on the temporary label and/or package leaflet must be highlighted an appropriate warning, e.g. ‘WARNING: Please follow this updated package leaflet because the enclosed package leaflet in the box is <not relevant> <no longer valid>.’,
– the name and address of the business entity who will carry out the activity of providing the foreign packaging with labels and package leaflet in the Slovene language.
– The MAH must have in accordance with the regulations, established a system of obligations and responsibilities of the business entities involved in providing the labels and package leaflet in the Slovene language to the medicinal products in foreign packaging and the release of batches.
– Depending on the individual case, other information and supporting documents may be requested by the JAZMP.
Source: Jazmp web page
