Borderline products refer to products that have characteristics of both medicines and medical devices, making their classification ambiguous. These products include items such as medical dressings, surgical lasers, and dental fillings, among others.
They are regulated under different frameworks in different countries, leading to potential inconsistencies in their classification and regulation. The European Medicines Agency and the European Commission have developed guidelines to provide clarity and harmonization in the regulation of borderline products in the European Union.
It is important for manufacturers and regulatory authorities to have a clear understanding of the classification of borderline products to ensure patient safety and facilitate market access for these products.
New Drugs, SND, FDC, API, Bulk Drugs, Test Licenses, BE NOC, etc. for importers, manufacturers and traders
Regulatory support for FSSAI. Import assistance, Licensing and registration, FSSAI compliance, Product Approval
Medical device registration, Import license, Clarification from CDSCO, Performance evaluation
Registration of biologicals, Import license, Test license, Export NOC, Regulatory support for CLAA
Registration of biologicals, Import license, Test license, Export NOC, Regulatory support for CLAA
Registration of biologicals, Import license, Test license, Export NOC, Regulatory support for CLAA
R.P/C.P
The medicines need to be handled with by a specialist, and for that matter, there is a requirement of a qualified pharmacist in case of retail drug license and in case of wholesale a graduate with 1 years experience or undergraduate having four years experience is must or any Diploma or Bachelor degree in Pharmacy.
Area For Drug Licence
For opening a pharmacy business, the carpet area of the pharmacy must be a minimum of 10 square meters, and in case the application is for both retail and wholesale pharmacy the minimum area prescribed in 15 square meters. The premises must be commercial and adequately ventilated.
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Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
Professionally impact distributed data via value-added experiences. Proacti incentivize 24/365 applications whereas turnkey total linkage. whiteboard multifunctional channels with interoperable value.
