Pharmaceutical regulations on the trade in medical oxygen – A comprehensive overview including wholesale and legal requirements

Medical oxygen plays a central role in modern healthcare. In addition to its clinical application, its trade is subject to strict pharmaceutical regulations. This blog post provides an overview of the relevant regulations that manufacturers, distributors, and wholesalers must comply with – including the legal requirements for operating as a wholesaler of medical oxygen.

1. Medical oxygen – What makes it a medicine?

Medical oxygen is used to support patients with oxygen deficiency, whether in emergency medicine, chronic respiratory diseases, or post-operative care. Due to its use in the treatment and prevention of health conditions, it is considered a medicinal product. This results in specific pharmaceutical regulatory requirements that must be met for its manufacture, storage, distribution, and dispensing.

2. Legal framework and guidelines

a) National legislation

In Germany, medical oxygen is subject to the provisions of the German Medicines Act (AMG) . This law regulates, among other things:

Approval: Only approved and tested products may be marketed. The approval procedures ensure that the oxygen meets the required quality and safety standards.
Manufacturing and quality control: Production must be carried out in accordance with Good Manufacturing Practices (GMP) . This includes detailed manufacturing processes, quality checks, and regular inspections by relevant authorities.
Labeling and packaging: Medical oxygen must be clearly labeled. Information on the active ingredient content, instructions for use, storage conditions, and expiration date are mandatory.

b) European requirements

In addition to national regulations, manufacturers and retailers must also comply with European directives:

EU Medicines Regulation: This sets common standards for all member states and promotes a single market for medicines.
CE marking: Medical oxygen classified as a medical device often also requires the CE marking, which confirms compliance with European safety, health and environmental protection requirements.

3. Authorisation and market surveillance

a) Admission procedure

Before medical oxygen can be marketed, it must undergo regulatory approval. This includes:

Quality testing: Laboratory tests and clinical studies prove that the product meets high safety and quality standards.
Documentation: Detailed manufacturing and testing processes must be documented and presented to regulatory authorities upon request.

b) Market surveillance and traceability

The competent authorities continuously monitor the market to ensure that only approved products are circulating. Measures include:

Sample checks: Regular inspections of production facilities and distribution channels.
Traceability: Every step from the manufacturer to the end user must be traceable. This is crucial for a quick and targeted response in the event of a product recall.

4. Special requirements in retail

a) Storage and transport

Pharmaceutical regulations stipulate specific storage and transport conditions:

Storage: Medical oxygen must be stored under controlled conditions to avoid contamination or deterioration. Important factors include temperature, humidity, and ventilation.
Transport: Transport takes place in certified containers that meet legal requirements. Likewise, the transport routes and conditions must be fully documented.

b) Training and information of staff

An essential aspect is the professional training of staff:

Handling the product: Employees in retail and logistics must be informed about the specific properties and risks of medical oxygen.
Safety regulations: Regular training ensures that everyone involved acts correctly in an emergency and adheres to strict safety regulations.

5. Wholesale of Medical Oxygen

Wholesalers play a crucial role in the supply chain and, as a link between manufacturers and end users (e.g., doctors' offices, hospitals, and pharmacies), assume special tasks and responsibilities:

a) Special requirements in wholesale

Authorisation and registration obligations:
Wholesalers must register with the relevant authorities, such as the Federal Institute for Drugs and Medical Devices (BfArM) or the relevant state authorities. They must also provide specific evidence of quality assurance and product traceability.
Securing the supply chain:
The wholesaler is responsible for ensuring that the entire supply chain complies with pharmaceutical regulations. This includes monitoring storage conditions, transport requirements, and compliance with safety standards.
Quality assurance:
In addition to regular supplier audits, random checks of delivered products are also necessary. Wholesalers must ensure that all products meet applicable quality standards and that there are no tampering or deviations.

b) Documentation and traceability

Detailed documentation:
All wholesale transactions must be fully documented. This includes recording order and delivery data to ensure rapid response in the event of a recall.
Exchange of information with suppliers and end users:
Wholesalers act as central information hubs. Effective information exchange regarding delivery conditions, quality standards, and potential safety risks is essential to ensure end-to-end traceability.

c) Training and Compliance

Training of wholesale staff:
Wholesale employees must be fully informed and regularly trained about the specific pharmaceutical regulations and the special requirements for trading in medical oxygen.
Compliance management:
Wholesalers must implement effective compliance management to monitor compliance with all legal and regulatory requirements. This includes internal audits and cooperation with external audit bodies.

6. Legal requirements for the wholesale trade of medical oxygen

To operate as a wholesaler of medical oxygen, additional legal requirements must be met. These relate to both organizational and technical aspects:

a) Registration and licensing

Official registration:
Potential wholesalers must register with the relevant drug authorities (e.g., the Federal Institute for Drugs and Medical Devices (BfArM) in Germany). This registration confirms that the company meets the necessary requirements for wholesale distribution.
Granting of a wholesale license:
In addition to registration, a special wholesale license is often required. This license proves that the wholesaler is capable of meeting strict quality and safety requirements.

b) Proof of expertise and organizational competence

Professional qualifications:
The operator must demonstrate that they have the necessary expertise and experience in handling medicinal products. This includes knowledge in the areas of quality management, storage, and transport of medicinal products.
Organizational requirements:
A functioning quality management system (QMS) must be implemented to ensure compliance with legal requirements. This includes, among other things, standardized processes for product storage, transport, and documentation.

c) Safety and quality management

Implementation of GMP standards:
Compliance with Good Manufacturing Practices (GMP) is also crucial in wholesale, particularly in the areas of storage and distribution.
Risk management:
Wholesalers must have effective risk management in place to identify and minimize potential threats in the supply chain at an early stage.

d) Regular audits and inspections

Internal and external audits:
Regular reviews and audits by internal control systems and external authorities are planned. These audits ensure that all processes comply with legal requirements.
Documentation requirements:
To ensure traceability and compliance, all processes and transactions must be documented in detail and made available for regulatory inspections at any time.

7. Challenges and future developments

The trade – especially the wholesale trade – of medical oxygen is constantly facing new challenges:

Digitalization and automation:
Modern IT systems can improve supply chain documentation and monitoring. Automated processes enable more efficient management and traceability.
Extended approval procedures:
With new product variants and innovative applications, additional approval procedures may become necessary, which requires continuous adaptation of the processes.
Sustainability and environmental protection:
The topic of sustainability is also gaining importance in the wholesale sector. Efficient logistics solutions and environmentally friendly storage concepts are increasingly being included in pharmaceutical regulatory assessments.

Conclusion

The trade in medical oxygen is subject to strict pharmaceutical regulations, which are regulated at both the national and European levels. From approval and manufacturing to storage, transport, and wholesale distribution – all steps are clearly defined and subject to regular inspections. Wholesalers play a key role in this process, acting as a link between manufacturers and end users, ensuring compliance with legal requirements and ensuring traceability.

To operate as a wholesaler of medical oxygen, additional legal requirements must be met. Official registration, proof of technical and organizational competence, robust quality management, and regular audits and inspections are essential. Only consistent compliance with these requirements can ensure that patients always receive a safe, high-quality product.

Manufacturers, distributors, wholesalers, and medical facilities should continuously stay informed about current regulatory changes and adapt their processes accordingly. This is the only way to ensure that safety and quality in the trade of medical oxygen are guaranteed at all times.

Stay informed, invest in compliance, and ensure your company meets all legal requirements – for a secure future in the medical oxygen trade!