Regulatory

NM Pharma’s main goal is to enhance and broaden our product portfolio by meeting new suppliers and manufacturers and sourcing the latest products in compliance with all industry regulations.

 

NM Pharma’s quality department is headed by a highly qualified and experienced team of pharmacists who handle regulatory matters such as registration of medicines in Malta through the relevant regulatory bodies and ensure that organizational measures exceed industry requirements. NM Pharma is well positioned to meet, support and handle products such as generic drugs, branded drugs, vaccines, controlled drugs, injectable drugs, medical devices, food supplements and more.

EXCELLENT QUALITY SYSTEMS

High standards in pharmaceutical procurement, handling and distribution of medicines to protect patient safety and the quality of the final product. This is achieved through strict adherence to regulatory requirements and quality standards.

Pharmaceutical Licences

NM Pharma holds both a Wholesale Dealer Licence (WDL) and a Goods Distribution Practice certificate (GDP) granted by the Malta Medicines Authority. The company is authorised to procure, supply and export medicinal products requiring ambient or cold chain storage conditions, immunological products as well as controlled drugs, such as narcotics.
Licence Number: WL 134

Product Licence Application

NM Pharma handles all the product registrations with the Malta Medicines authority. Product registration can either be done through and MRP Day Zero application, a 126(A) application or a Parallel Import application.

Quality Management System

Through our high-level quality management system, we ensure that all activities performed within the company comply with Good Distribution Practice (GDP). The system is fully documented with standard operating procedures (SOP’s) available for all activities performed. These documents define how the quality system is controlled through change controls, deviations, complaints, CAPAs, training of personnel etc.

Pharmacovigilance

As part of our Quality Management system, NM Pharma has high standard of Pharmacovigilance which aim to protect public health. Together with the supplier / Marketing Authorisation Holder (MAH), we assess drug safety of medicinal products by monitoring and reporting adverse reactions, carrying out signal detection, compliance monitoring and responding to medical enquiries as required.

Medical Device Regulation (MDR)

NM Pharma has been registered as an importer for Medical Devices with the local competent authority, as well as EUDAMED. The Quality Management system has been adapted to abide by the Medical Device Regulations.