MANA PHARMA

Quality

Our purpose is to build and maintain solid relationships with our customers and suppliers, based on trust, offering a quality service at competitive prices.

Our certifications endorse us

MANA PHARMA has Licences/Authorisations, Registrations and Certifications, which provide the Organisation 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.

Authorisation 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).

Authorisation as a Wholesale Pharmaceutical Distribution Warehouse for medicinal products for human (and veterinary) use.

MANA PHARMA’s main activity is the Wholesale Pharmaceutical Distribution of Medicines in countries inside and outside the EU.

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 that occur 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 Authorisation 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 authorised to transact in different types of medicines:

With marketing authorisation in EEA countries
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 authorisation in EEA countries
No marketing authorisation in the EEA and intended for the EEA market.

We are authorised 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.

Authorisation as a TAC

Marketing Authorisation Holder

We are responsible for maintaining the Marketing Authorisation for the medicines for which we are the Marketing Authorisation 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 authorisation

Pharmaceutical Wholesaler Authorisation

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

Operating Licence as a Medical Devices Importer

This Licence 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 PS 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 RUESA, and we are certified in BPDs (APIs).

Other registrations that allow us to develop 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 Defence 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)