Alims ALiMS Vlada Republike Srbije
ALiMS
DOCUMENTATION
 Documentation necessary for the product classification  Potrebna dokumentacija za klasifikaciju proizvoda  Potrebna dokumentacija za klasifikaciju proizvoda


Medicinal products:

 Notice about the manner of the submission of application and preparation of documentation regarding the marketing authorization for a medicinal product  Obaveštenje o načinu podnošenja zahteva i pripreme dokumentacije za izdavanje dozvole za stavljanje leka u promet  Pravilnik o postupku i uslovima za dobijanje dozvole za stavljanje leka u promet
 Instructions regarding the application for the preparation of documentation for notice of Type Ia and Ib Variation  Uputstvo u vezi zahteva za pripremu dokumentacije za prijavu Varijacija tipa Ia i Ib  Uputstvo u vezi zahteva za pripremu dokumentacije za prijavu Varijacija tipa Ia i Ib


Medical devices:

 Application Forms-Required medical devices MA documentation    Application Forms-Required medical devices MA documentation
 Instructions for the preparation of documentation regarding the marketing authorization for a medical device with the CE marking.  Instructions for the preparation of documentation regarding the marketing authorization for a medical device with the CE marking.  Instructions for the preparation of documentation regarding the marketing authorization for a medical device with the CE marking.
 Instructions for the preparation of documentation regarding the marketing authorization for a medical device based on the regulations in force prior to the new Law on Medicinal Products and Medical Devices coming into force, those medical devices bearing the CE marking (in accordance with Article 159 of the existing Law).  Instructions for the preparation of documentation regarding the marketing authorization for a medical device based on the regulations in force prior to the new Law on Medicinal Products and Medical Devices coming into force, those medical devices bearing the CE marking (in accordance with Article 159 of the existing Law)  Instructions for the preparation of documentation regarding the marketing authorization for a medical device based on the regulations in force prior to the new Law on Medicinal Products and Medical Devices coming into force, those medical devices bearing the CE marking (in accordance with Article 159 of the existing Law)
 Instructions for the preparation of documentation for the marketing authorization for a medical device which is not compliant with regulations of the EU directives for medical devices, i.e. which do not have the CE marking.  Instructions for the preparation of documentation for the marketing authorization for a medical device which is not compliant with regulations of the EU directives for medical devices, i.e. which do not have the CE marking.  Instructions for the preparation of documentation for the marketing authorization for a medical device which is not compliant with regulations of the EU directives for medical devices, i.e. which do not have the CE marking.