In the pharmaceutical sector, the distribution and marketing of medicines are subject to strict regulations to ensure drug quality, safety, and efficacy. One of the key players in this process is the Marketing Authorization Holder (MAH) Laboratory, an essential entity in the pharmaceutical supply chain.
In this article, we will explore in depth what an MAH Laboratory is, its functions, responsibilities, and its importance in the pharmaceutical market. Additionally, we will highlight the role of MANA PHARMA as an MAH Laboratory and its support for other Marketing Authorization Holders in the European Union.
Let’s start from the beginning…
What is an MAH Laboratory?
A Marketing Authorization Holder (MAH) Laboratory is the legal entity responsible for the commercialization of a medicine in a specific country or region. This laboratory obtains authorization from regulatory authorities (such as the Spanish Agency of Medicines and Medical Devices, AEMPS, in Spain) to market a drug.
The MAH ensures that the medicine complies with the quality, safety, and efficacy requirements established by current regulations. Additionally, it oversees the drug’s manufacturing, storage, distribution, pharmacovigilance, and traceability once the product is on the market.
Functions and Responsibilities of an MAH Laboratory
As the guarantor of the legality and quality of marketed medicines, the MAH Laboratory assumes key responsibilities throughout the product’s lifecycle. From initial authorization to post-market monitoring, its functions cover regulatory, technical, and safety aspects, all within the legal pharmaceutical framework.
Below, we detail its main obligations:
Obtaining and Maintaining Marketing Authorization
The MAH is responsible for applying for and maintaining the marketing authorization of a medicine before Health Authorities. This involves submitting all necessary technical and clinical documentation to prove compliance with regulatory standards.
Quality Control and Regulatory Compliance
The MAH Laboratory must ensure that medicines are manufactured in accordance with Good Manufacturing Practices (GMP), as well as stored and distributed following Good Distribution Practices (GDP). This includes:
- Verifying the quality of raw materials.
- Supervising production processes.
- Ensuring each batch meets authorized quality specifications and is released by a Qualified Person (QP).
- Guaranteeing proper storage and transportation conditions.
Traceability and Anti-Counterfeiting Measures
The MAH Laboratory must ensure traceability and security throughout the supply chain, from manufacturing to patient dispensing. To achieve this, it implements various measures:
- Tamper-evident security devices to prevent manipulation of human-use medicines.
- Participation in the European Medicines Verification System (EMVS/NMVS) to track medicines within the European market.
- Inclusion of a Unique Identifier (UI) on secondary packaging to verify each unit at any point in the supply chain until patient dispensing.
Pharmacovigilance
Once the medicine is on the market, the MAH is responsible for monitoring adverse effects, reporting any incidents to Health Authorities. This is crucial to ensuring patient safety.
Distribution and Logistics
The MAH must have the necessary infrastructure for storage and distribution, ensuring that product quality is not compromised during transportation.
Infrastructure and Regulatory Compliance
As a Marketing Authorization Holder (MAH) Laboratory for human-use medicines, MANA PHARMA complies with all legal and technical requirements to ensure proper commercialization, distribution, and preservation of medicines.
At MANA PHARMA, we have:
- Adequate facilities and technical equipment for medicine storage and distribution.
- Control measures ensuring compliance with health regulations.
- Optimized logistics processes to maintain product integrity.
Local Representation of MAH Laboratories in Spain
In addition to being an MAH Laboratory, MANA PHARMA acts as a Local Representative in Spain for other MAH Laboratories based in the European Union or outside the EU. This involves:
- Supporting commercialization, pharmacovigilance, and distribution in the Spanish market.
- Facilitating interaction with competent Authorities (AEMPS, Ministry of Health).
- Assisting in the maintenance of medicine registrations in Spain.
Benefits of Working with MANA PHARMA
Partnering with an experienced MAH Laboratory like MANA PHARMA offers multiple advantages:
- Guaranteed regulatory compliance: We ensure all processes meet EU and Spanish regulations.
- Specialized logistics: Our storage and distribution systems preserve medicine quality.
- Full regulatory support: We advise and manage procedures before Health Authorities.
Trust MANA PHARMA
A Marketing Authorization Holder (MAH) Laboratory is a fundamental player in the pharmaceutical industry, ensuring that medicines meet the highest quality, safety, and efficacy standards.
If your company needs a trusted partner for the commercialization and distribution of medicines in Spain, rely on MANA PHARMA: we provide the expertise and infrastructure needed to meet all regulatory and quality requirements.
