MANA PHARMA

Quality

MANA PHARMA Quality Our aim is to generate and maintain solid relationships with our Customers and Suppliers, based on trust, offering a quality service.

Our certifications endorse us

MANA PHARMA has Licenses/Authorizations, Registrations and Certifications, which provide the Organization with the tools to develop our business within the legal framework, and also the possibility of offering our clients a wide range of products and services.

Authorization as a Wholesale Pharmaceutical Distribution Entity of Medicines for Human Use allows us to carry out our main task as an Exporter of medicines. The Good Distribution Practices (GDP) Certification guarantees the implementation of a Quality Management System in accordance with the European Commission Guidelines of 5 November 2013 on good distribution practices for medicinal products for human use (2013/C 343/01).

Authorization as a Wholesale Pharmaceutical Distribution Warehouse of medicines for human (and veterinary) use.

The Wholesale Pharmaceutical Distribution of Medicines in countries inside and outside the EU is the main activity carried out by MANA PHARMA.

It is worth mentioning the outstanding health activity carried out by MANA PHARMA in Spain, related to Medicines for Special Situations (MSE), in collusion with the Health Authorities, thus contributing to alleviate the lack of supply of medicines produced in our country. Furthermore, MANA PHARMA distributes medicines in Spain from European TAC Laboratories that have placed their trust in us, with MANA PHARMA acquiring the role of Local Representative vis-à-vis the Spanish Health Authorities.

Presencia Internacional

The scope of the Authorization as a Wholesale Pharmaceutical Distribution Warehouse enables MANA PHARMA to carry out activities related to the procurement, preservation or storage, supply and export of medicines:

We are authorized to transact in different types of medicines:

Without marketing authorization in the EEA and intended for the EEA market.
No marketing authorisation in the EEA and intended for the EEA market.

Narcotic and psychotropic drugs, blood derivatives, immunological, thermolabile, highly active drugs (cytostatics and immunosuppressants), as well as veterinary drugs.

With marketing authorization in EEA countries
Without marketing authorization in the EEA and intended for the EEA market.

We are authorized to transact in different types of medicines:

Narcotic and psychotropic drugs, blood derivatives, immunological, thermolabile, highly active drugs (cytostatics and immunosuppressants), as well as veterinary drugs.

Authorization as a MAH

Marketing Authorization Holder

We are responsible for maintaining the Marketing Authorization for the medicines for which we are the Marketing Authorization Holder.

We carry out storage and distribution activities (including export) of these medicines, applying quality standards in accordance with the GxPs. We also carry out pharmacovigilance activities to ensure that the medicines administered to patients meet the requirements that ensure their quality, safety and efficacy.

WDA Authorization

Pharmaceutical Wholesaler Authorization

Pharmaceutical Wholesale Distribution of Medicines in countries inside and outside the EU is the main activity carried out by MANA PHARMA.

It is worth mentioning the outstanding health activity carried out by MANA PHARMA in the national territory, related to Medicines in Special Situations (MSE), in collusion with the Health Authorities, thus contributing to alleviate the lack of supply of medicines produced in our country.

Operating License as an Importer of Medical Devices

This License allows us to import Medical Devices (MD) and In Vitro Diagnostic Devices (IVD) from non-EU countries into the EEA, according to European requirements and regulations. Imported medical devices can be marketed in the EEA once they have been notified.

The PS distributed or exported by MANA PHARMA complies with all the updated EEA guarantees and the International Standards ISO 13485:2016.

RUESA

Register of Manufacturers, Importers and Distributors of Active Substances

We have the capacity to import and export active pharmaceutical ingredients. We are registered in Register of Manufacturers, Importers and Distributors of Active Substance (RUESA) of the Spanish Medicines and Medical Devices Health Authority (AEMPS), and we are certified in GDPs (APIs).

Other registrations that allow us to carry out our activity are:

Census of the Official Chamber of Commerce, Industry and Services of Madrid
NIMA (Environmental Identification Number)
Special Register for Foreign Trade in Scheduled Chemicals (Category 2 and 3)
Special Register of Operators of Foreign Trade in Defense and Dual-Use Material
General Register of Operators of Scheduled Chemicals (Category 2 and 3)
General Sanitary Registry of Food and Food Companies (RGSEAA), with code 26 (special food and food supplements) and code 40 (multipurpose food).
ROLECE (Official Registry of Bidders and Classified Companies of the Public Sector)
Compliance CMS: Crime Prevention, Criminal Compliance Policy and Code of Ethics and Conduct
SGC de LOPD (Organic Law 3/2018, of 5 December, on the Protection of Personal Data and the guarantee of digital rights)