1. Introduction

Vaccine production licensing in Morocco is governed by a combination of pharmaceutical legislation, public-health regulations, manufacturing standards, biological-product controls, quality-assurance requirements, and administrative supervision.

Vaccine production is a highly regulated activity because vaccines are biological medicinal products that must satisfy strict requirements concerning safety, efficacy, quality, sterility, potency, and manufacturing consistency.

The Moroccan regulatory framework seeks to ensure that:

Vaccine manufacturers operate under legally authorized conditions.

Manufacturing facilities comply with Good Manufacturing Practices (GMP).

Vaccines undergo appropriate quality and safety assessments.

Products receive the necessary marketing authorization before being placed on the market.

Manufacturing defects and adverse events are reported and investigated.

Public authorities can suspend or withdraw authorizations where public health is endangered.

An important legal distinction is that authorization to operate a pharmaceutical manufacturing establishment is not necessarily the same as authorization to manufacture and market a particular vaccine. Both institutional and product-specific regulatory requirements must be considered.

2. Principal legislative framework

A. Law No. 17-04: Code of Medicines and Pharmacy

The principal legislation is Law No. 17-04, promulgated by Dahir No. 1-06-151 of 22 November 2006.

It establishes the legal framework for:

Pharmaceutical manufacturing establishments.

Pharmaceutical product registration.

Manufacturing and quality control.

Importation and exportation of medicines.

Pharmaceutical professionals' responsibilities.

Suspension and withdrawal of marketing authorizations.

Administrative inspections and enforcement.

Article 8 is particularly important. It establishes that a medicine can receive marketing authorization only after the required testing and where the manufacturer has manufacturing and control methods capable of guaranteeing product quality during industrial production.

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Article 11 preserves the manufacturer's and marketing-authorization holder's legal responsibility for manufacturing defects and harmful effects, even after regulatory authorization.

Articles 14 and 15 permit suspension or withdrawal of marketing authorization where a product presents a public-health danger or fails to meet applicable pharmaceutical requirements.

Legal significance: A vaccine manufacturer's licence does not provide immunity from civil, administrative, or criminal responsibility for defective products.

B. Article 75: Prior authorization for pharmaceutical establishments

Article 75 of Law No. 17-04 requires prior administrative authorization for the establishment of a pharmaceutical enterprise.

The application must provide information concerning:

The proposed location of the establishment.

Its operating arrangements.

The identity and qualifications of the responsible pharmacist.

The qualifications of delegated and assistant pharmacists, where applicable.

The quality of the proposed facilities and equipment.

Compliance with technical standards established by the competent administration.

The National Council of the Order of Pharmacists is consulted in the authorization process.

This requirement is particularly relevant to vaccine manufacturing facilities because biological production requires specialized equipment, controlled environments, trained personnel, and appropriate quality-control systems.

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C. Decree No. 2-07-1064 of 9 July 2008

This decree regulates the practice of pharmacy and the creation and opening of pharmacies and pharmaceutical establishments.

It provides an implementing framework for the establishment and operation of industrial pharmaceutical enterprises.

For vaccine manufacturers, the regulatory implications include:

Properly constituted pharmaceutical establishments.

Appropriate professional supervision.

Qualified technical management.

Compliance with premises and operational requirements.

Regulatory oversight of pharmaceutical activities.

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D. Decree No. 2-14-841: Marketing authorization

Decree No. 2-14-841 governs the marketing authorization (Autorisation de Mise sur le Marché or AMM) of medicines for human use.

The AMM is a separate regulatory requirement from authorization to establish and operate a manufacturing facility.

A vaccine must have an appropriate product-specific authorization before ordinary commercial marketing. The regulatory assessment concerns the product's quality, safety, efficacy, manufacturing process, and supporting technical documentation.

The distinction is important because a manufacturer may have permission to operate a pharmaceutical factory without automatically having permission to market every vaccine manufactured there.

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E. Law No. 10-22 and the Moroccan Medicines and Health Products Agency

The institutional framework has also changed.

Under Law No. 10-22, the Moroccan Medicines and Health Products Agency (AMMPS) assumed important pharmaceutical regulatory responsibilities.

According to the Agency's official communication of 6 June 2025, effective 16 June 2025, responsibility for authorizing industrial pharmaceutical establishments and wholesale distributors transferred from the General Secretariat of the Government to AMMPS.

AMMPS

Consequently, the Agency plays an important role in the authorization and supervision of pharmaceutical manufacturing establishments.

3. Licensing procedure for vaccine production

The licensing process can be understood through the following stages.

Stage 1: Establishment of the pharmaceutical company

The applicant must establish a legally compliant pharmaceutical enterprise.

Its proposed operations must be consistent with the pharmaceutical legislation and applicable corporate and professional requirements.

The applicant must identify the responsible pharmacist and provide information about the technical management of the enterprise.

Stage 2: Preliminary authorization

The proposed manufacturing establishment must obtain the required prior administrative authorization.

The application should address:

Site location and layout.

Production capacity.

Manufacturing equipment.

Personnel qualifications.

Quality-control facilities.

Storage and distribution arrangements.

Environmental and safety controls.

For biological products, the regulator should also be able to assess whether the proposed facility can control contamination and maintain appropriate manufacturing conditions.

Stage 3: Construction and technical inspection

After preliminary approval, the applicant develops the facility in accordance with the approved plans and applicable technical requirements.

The competent authority may inspect the establishment to determine whether its actual facilities correspond to the approved application.

Important areas include:

Cleanrooms and controlled production environments.

Sterilization and contamination-control systems.

Temperature-controlled storage.

Biological quality-testing laboratories.

Production documentation and traceability systems.

Waste-management and biosafety arrangements.

Stage 4: Final authorization to operate

The manufacturer must complete the applicable administrative and technical requirements before commencing regulated pharmaceutical manufacturing operations.

A facility should not assume that preliminary approval alone permits unrestricted commercial production.

Stage 5: Product-specific marketing authorization

The vaccine must undergo the applicable registration and assessment procedure.

A typical dossier for a biological vaccine includes:

The regulator evaluates whether the vaccine satisfies the relevant requirements before granting the AMM.

Stage 6: Good Manufacturing Practices

Vaccine manufacturing requires a robust quality-management system.

GMP compliance is important because vaccines are sensitive biological products whose characteristics can be affected by manufacturing conditions.

The manufacturer should maintain:

Qualified personnel and documented training.

Validated manufacturing processes.

Controlled production environments.

Validated cleaning and sterilization procedures.

Batch production records.

Laboratory testing and quality assurance.

Deviations and corrective-action records.

Product traceability and recall procedures.

A manufacturing licence should not be interpreted as permission to disregard GMP obligations.

4. Special regulation of vaccine batch release

One of the most important developments in Moroccan vaccine regulation is the introduction of official batch-release requirements.

A. Decree-Law No. 2-24-728 of 27 September 2024

This decree-law supplements Law No. 17-04 by introducing Articles 17-1 to 17-4.

Its principal objective is to ensure that individual vaccine batches are independently assessed before being placed on the market.

Under Article 17-2:

Every human vaccine batch manufactured in Morocco must obtain an official batch-release certificate.

Imported human vaccine batches are also covered.

The certificate must be obtained before the batch is placed on the market.

The certificate does not remove the manufacturer's or responsible pharmacist's legal responsibilities.

Article 17-3 provides an exemption for vaccine and serum batches acquired by Morocco through UNICEF.

Article 150-1 establishes a financial penalty of MAD 100,000 to MAD 1 million for violating the batch-release requirement. The fine doubles in cases of repetition.

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B. Decree No. 2-24-729 of 30 September 2024

This decree establishes the procedure for obtaining official vaccine batch-release certificates.

The application must contain:

An application signed by the responsible pharmacist.

A summary protocol describing manufacturing and control stages.

Results of manufacturing and quality-control tests.

Evidence of compliance with transport and storage conditions.

The vaccine's marketing-authorization reference.

Other supporting documents considered useful.

For imported vaccines, additional documentation is required, including the country-of-origin batch-release certificate, relevant health visa information, and applicable inspection and adverse-event reports.

The Agency may also require vaccine samples and reagents for analytical testing.

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Decision-making deadlines

These periods are subject to the applicable statutory conditions. Requests for additional information suspend the ordinary decision period.

If the batch fails the release requirements, the decree provides for its destruction under the applicable rules, with a destruction report sent to AMMPS.

In an epidemic, extreme emergency, or national calamity, parallel testing arrangements may be used for locally manufactured batches.

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C. AMMPS guidelines of 9 February 2026

An important recent development is the publication of the official guideline concerning the release of human vaccine and serum batches.

The guideline became effective on 9 February 2026 and applies to human vaccines and sera subject to official batch release.

Its objectives include:

Harmonizing national batch-release practices.

Clarifying responsibilities among regulatory stakeholders.

Strengthening regulatory compliance.

Improving vaccine safety.

Aligning national practices with World Health Organization standards.

This is particularly significant because it strengthens the practical implementation of Morocco's vaccine-control framework.

AMMPS

5. Responsibilities of vaccine manufacturers

A. Manufacturing quality

Manufacturers must ensure that the vaccine is consistently produced according to the approved manufacturing process.

A manufacturer cannot freely change its production method, composition, or essential product characteristics without considering the applicable variation and authorization requirements.

B. Responsible pharmacist

The responsible pharmacist has an important statutory role under Article 117 of Law No. 17-04.

The pharmacist is responsible for supervising pharmaceutical operations, including:

Procurement and control of raw materials.

Manufacturing and packaging.

Quality control during production.

Testing of finished products.

Storage and distribution.

Product release.

Pharmacovigilance and product recalls.

The establishment also retains its own legal responsibility.

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C. Pharmacovigilance

Vaccine manufacturers and authorization holders must participate in the applicable pharmacovigilance system.

This involves:

Monitoring adverse reactions.

Reporting relevant safety information.

Investigating unexpected events.

Evaluating possible manufacturing-related problems.

Cooperating with regulatory authorities.

Implementing corrective measures where necessary.

Article 6 of Law No. 17-04 provides the statutory foundation for collecting and evaluating information about unexpected or toxic effects following marketing authorization.

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D. Suspension and withdrawal

Where a vaccine presents a public-health danger, the regulatory authorities can take protective measures.

Under Article 14, a reasoned decision may suspend the marketing authorization and prohibit sales pending a final decision. The holder must be given an opportunity to explain its position.

Article 15 identifies circumstances in which authorization may be suspended or withdrawn, including:

Lack of the expected therapeutic effect.

Incorrect qualitative or quantitative composition.

Failure to conduct required manufacturing or quality-control tests.

Failure to comply with applicable regulatory requirements.

The purpose is to prevent unsafe or non-compliant vaccines from remaining in circulation.

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6. Relevant Moroccan case laws

Important judicial qualification: There is limited publicly identifiable Moroccan reported jurisprudence specifically addressing the licensing of vaccine manufacturing facilities. The following decisions concern related pharmaceutical authorization and intellectual-property issues. They are useful for interpreting the legal environment, but should not be presented as direct vaccine-production licensing precedents.

Case 1: Casablanca Commercial Court of Appeal, Decision No. 2080, 29 September 2020

Related pharmaceutical authorization case

Reference: Case No. 2020/8225/1298.

Subject: Pharmaceutical trademark infringement and the relationship between marketing authorization and intellectual-property protection.

The dispute concerned the use of a pharmaceutical product name and allegations of trademark infringement.

One party argued that the existence of an administrative authorization to market the medicine affected the court's jurisdiction and the ability to order provisional measures.

The Court of Appeal considered the distinction between:

Administrative authorization relating to a medicine.

Intellectual-property rights relating to the product's trademark.

The court recognized the commercial court's jurisdiction over the trademark-infringement dispute and the availability of provisional judicial protection under Article 203 of Industrial Property Law No. 17-97.

Legal principle: Administrative authorization to market a pharmaceutical product does not automatically resolve disputes concerning trademark rights.

Relevance to vaccine production: A vaccine manufacturer must independently comply with pharmaceutical authorization requirements and intellectual-property obligations. Regulatory approval is not a substitute for a valid trademark or manufacturing licence.

Jurisprudence

Case 2: Moroccan Court of Cassation, Commercial Chamber, 4 March 2021

Related pharmaceutical licensing case

Subject: Trademark non-use and pharmaceutical marketing authorization.

The dispute concerned the alleged non-use of a registered trademark for pharmaceutical products.

The Court of Cassation emphasized that a court examining whether a trademark had genuinely been used must consider the relevant evidence, including:

Pharmaceutical marketing authorization.

Licensing documentation.

Correspondence between the parties.

Evidence of commercial exploitation with the trademark owner's consent.

The court held that excluding such evidence without proper examination could result in an insufficient legal basis for the judgment.

Legal principle: Pharmaceutical administrative documentation can be relevant evidence in commercial and intellectual-property litigation.

Relevance to vaccine production: Where vaccine manufacturing takes place under a technology-transfer, licensing, or subcontracting arrangement, the parties should maintain clear documentation establishing their respective regulatory and contractual rights.

Jurisprudence

Case 3: Statutory enforcement under Articles 14, 15 and 150-1 of Law No. 17-04, as amended

This is not a judicial precedent but an important statutory enforcement framework.

It provides three distinct forms of regulatory intervention:

Suspension of marketing authorization where a product presents a public-health danger.

Withdrawal of authorization where statutory grounds are established.

Financial penalties for placing vaccine or serum batches on the market without the required official release certificate.

The batch-release penalty is MAD 100,000 to MAD 1 million, doubled in cases of repetition.

Legal significance: Moroccan vaccine regulation combines preventive administrative supervision with financial and other legal enforcement mechanisms.

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7. Role of Institut Pasteur of Morocco

معهد «باستور» بالدار البيضاء.. مؤسسة استراتيجية في تطور مستمر

Institut Pasteur du Maroc

The Institut Pasteur's Serum and Vaccine Center provides a practical example of Morocco's public-sector vaccine manufacturing framework.

Casablanca, Morocco

The Serum and Vaccine Center is a public industrial pharmaceutical establishment supervised by the Ministry of Health.

Its activities include the manufacture, importation, and marketing of vaccines, sera, and biological products. It is subject to Law No. 17-04.

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COVID-19 vaccine manufacturing project

Morocco's COVID-19 vaccine project provides an important practical illustration.

The Serum and Vaccine Center was assigned pharmaceutical responsibilities for the Sinopharm vaccine fill-and-finish project.

Its responsibilities included:

Filing the vaccine registration application.

Managing technological transfer.

Supervising filling and packaging operations.

Coordinating analytical testing.

Conducting quality-control activities.

Managing batch-release procedures.

Monitoring adverse events after administration.

This example demonstrates that even where vaccine technology originates abroad, domestic manufacturing and packaging operations must be integrated into the Moroccan pharmaceutical regulatory framework.

Institut Pasteur du Maroc

8. Major legal challenges

Several regulatory challenges arise in the Moroccan vaccine-manufacturing sector.

A. Technology-transfer disputes

Foreign companies may transfer vaccine technology to Moroccan pharmaceutical manufacturers.

However, contractual permission to use a technology does not itself constitute regulatory authorization.

The parties must establish:

Ownership and permitted use of manufacturing technology.

Responsibility for production quality.

Regulatory documentation obligations.

Confidentiality and data-protection requirements.

Responsibility for manufacturing defects.

Allocation of product-liability risks.

B. Cold-chain and storage liability

Vaccines may lose effectiveness when exposed to inappropriate temperatures.

Manufacturers and distributors must establish appropriate storage and transport procedures.

Where temperature-control failures affect vaccine quality, the responsible parties may face regulatory investigations and liability.

C. Emergency manufacturing

During epidemics, Morocco may need accelerated vaccine production and regulatory assessment.

Decree No. 2-24-729 recognizes special arrangements for emergencies and national immunization programmes.

However, accelerated review should not be confused with unrestricted permission to manufacture or distribute unapproved vaccines.

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9. International legal framework

Morocco's vaccine-production regulation also operates within an international public-health environment.

Important international standards and frameworks include:

World Health Organization (WHO): Good Manufacturing Practices and vaccine quality standards.

WHO Global Benchmarking Tool: Regulatory-system assessment and strengthening.

WHO vaccine prequalification: International assessment relevant to vaccines intended for procurement by United Nations agencies.

International Health Regulations 2005: International public-health cooperation.

TRIPS Agreement: Pharmaceutical patent protection and public-health flexibilities.

Cartagena Protocol on Biosafety: Relevant where vaccine production involves living modified organisms within the Protocol's scope.

These instruments provide relevant international standards, but their application depends on their respective legal scope and Morocco's domestic implementing framework.

10. Recommendations for improving vaccine-production licensing

Morocco could further strengthen its regulatory system through:

Transparent electronic licensing procedures.

Regular GMP inspections of manufacturing facilities.

Improved regulatory cooperation with WHO-recognized authorities.

Clear rules for technology-transfer arrangements.

Stronger biological-product testing capacity.

Effective monitoring of manufacturing deviations.

Improved vaccine cold-chain traceability.

Clear procedures for emergency production.

Greater transparency concerning batch-release decisions.

Stronger coordination between manufacturers, research institutions, and regulators.

11. Conclusion

Regulation of vaccine production licensing in Morocco is principally governed by Law No. 17-04, its implementing decrees, and the institutional framework established under Law No. 10-22.

The system distinguishes between authorization of a pharmaceutical manufacturing establishment, authorization of a particular vaccine for marketing, and official release of individual vaccine batches.

The introduction of Articles 17-1 to 17-4 through Decree-Law No. 2-24-728 and the implementation framework under Decree No. 2-24-729 have strengthened vaccine-specific regulatory control.

The February 2026 AMMPS batch-release guideline represents a further development in the national regulatory framework.

Although directly relevant reported vaccine-manufacturing licensing judgments are limited, Moroccan pharmaceutical and trademark decisions demonstrate the importance of administrative authorization, documentary evidence, intellectual-property compliance, and judicial protection.

Ultimately, the Moroccan framework seeks to balance industrial pharmaceutical development, technological innovation, access to vaccines, and the protection of public health.

12. Important legislation and judicial references

Official and research sources

WIPO – Moroccan Law No. 17-04

Moroccan Ministry of Health – Law No. 17-04 (PDF)

Official Bulletin No. 7340 – Decrees 2-24-728 and 2-24-729

AMMPS – Vaccine batch-release guideline, February 2026

Institut Pasteur – Vaccine production project

Casablanca Commercial Court of Appeal – Decision No. 2080

Research note: This is an academic legal overview, not an exhaustive verification of every subsequent amendment or unpublished judgment. For an actual licensing application, the current AMMPS requirements and applicable implementing orders should be checked.