![]() Modification on the label of the drug (packaging and/ or labelling card)Ģ5 Dinars fees on changing the packaging and/or the labelling card Submitting an objection to the decision of the committeeĬhange the shelf life of a registered product (extension or reduction ) / change the shelf life of a product after opening or dissolutionĬhange the packaging material for the productĢ5 Dinars fee for any modification of the registered drug.Ĭhange the name of a manufacturing site without changing the approved addressĢ5 Dinars on any change on the registered medication.ġ00 Dinars for stability study (when needed).ġ00 Dinars fee for new internal leaflet in case the leaflet was affected by the storage conditions.Ģ5 Dinars fee on any change on registered medication. The registration of pharmaceuticals used in nuclear medicine (cold kit)ġ00 Dinars registration fee for a drug with a similar.ġ00 Dinar stability study assessment fee.Īpplication for registration of medicines that have a similarġ00 Dinars fee for a drug with a registered similar.ġ00 Dinars stability study assessment fee and 25 Dinars analysis fee.Ĥ00 Dinars bioequivalence study evaluation fee (or 100 Dinars comparative solubility study evaluation fee if exception is requested) 10 Dinars guarantee fee (if needed).ġ00 Dinars stability study assessment fee.Ĥ00 Dinars bioavailability study assessment fee.Ĥ00 Dinars fee for evaluation of clinical studies. Submitting a file for a drug manufacturing siteħ00 Dinars for each production line required to be approved in the manufacturing site.Īpproval of registration of a new plant-based drugġ000 Dinars fees for a new plant-based medicine or 100 Dinars fees for a similar registered herbal medicine.ġ00 Dinars assessment fee for stability study. ![]() Transferring a manufacturing site for a registered drugġ00 Dinars for a stability study of the product from the new site.ġ00 Dinars comparative solubility study fees (if needed)ġ00 Dinars internal leaflet fee when any change occurs on itĤ00 Dinars evaluation fee for the study of bioequivalence (if needed).Ģ5 Dinars fee for the updating of the external cover. Preliminary classification of plant/ vitamin/ food productsĢ5 Dinars initial classification service feeĪdding a new production line for a drug at an approved manufacturing siteħ00 Dinars fee for each new production line.Ģ5 Dinars modification fee for any procedure on any manufacturing site. Registration of infant formula, special formula and their complementary foodsĪdding a new indication, a new age group, a new treatment dose, and a new method of internal leaflet administration.ħ00 Dinars as manufacturing site accreditation fee.Īpproval of a manufacturing facility for radioactive elements or pharmaceuticals used in nuclear medicine (cold kit)Ĥ00 Dinars approval fee for new indication (in case the committee decides to consider the indication as new). ![]() ![]() Accreditation of an infant milk company, special formula, and supplemental meals for infantsħ00 Dinars manufacturing site accreditation fee. ![]()
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