1. Introduction

The regulation of stem cell importation and exportation in Morocco is an important part of biotechnology law, medical law, pharmaceutical regulation, bioethics and international health governance.

Stem cells are biological materials capable of self-renewal and differentiation into specialised cells. They are used in several medical and scientific fields, including:

Haematopoietic stem cell transplantation for blood disorders.

Regenerative medicine and tissue repair.

Bone marrow transplantation.

Cellular and gene therapies.

Biomedical research and clinical trials.

Experimental treatment of degenerative diseases.

International transportation of stem cells raises legal questions concerning donor consent, human dignity, biological-material ownership, patient safety, traceability, infectious-disease prevention, commercial exploitation and institutional accountability.

Morocco does not appear to have a single comprehensive statute exclusively governing the import and export of every category of stem cell. Instead, the regulatory framework is assembled from legislation on human organs and tissues, biomedical research, pharmaceutical products, assisted reproduction and administrative controls over cellular therapies.

The distinction between stem cells, human organs, reproductive tissues and medicinal products is particularly important because different legal provisions may apply to each category.

2. Principal Legislative Framework in Morocco

The principal legal instruments include:

The Moroccan Ministry of Health identifies Laws 16-98 and 28-13 among its principal instruments governing medical practices and biomedical research.

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3. Regulation Under Law No. 16-98: Human Organs and Tissues

Law No. 16-98, promulgated by Dahir No. 1-99-208 of 25 August 1999, is central to the regulation of human organ and tissue transplantation.

Its importance for stem cell regulation arises from the relationship between cellular preparations and human biological tissues.

Article 27: Import and export restrictions

Article 27 provides that the importation and exportation of human organs are prohibited unless the administration grants authorisation after receiving the opinion of the National Council of the Order of Physicians.

This provision establishes an administrative-control mechanism rather than allowing unrestricted international movement of human biological material.

Article 28: Eligible importing institutions

Article 28 restricts authorised organ imports to hospital establishments authorised to undertake organ removal and transplantation.

Article 29: Export controls

Article 29 restricts authorised exports to organisations appearing on an administrative list established pursuant to an agreement between Morocco and the foreign state concerned.

These provisions are important when determining whether a particular stem-cell preparation falls within the statutory category of regulated human tissue or another category of biological material. They should not automatically be interpreted as applying identically to every isolated cell product.

Sources:

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4. The 2019 Ministry of Health Circular on Cellular Therapies

One of the most significant administrative developments is the Ministry of Health's announcement of 6 June 2019.

The Ministry restricted the collection, processing and administration of autologous cellular-therapy preparations to public or private university hospital centres (CHUs) specifically approved by the Ministry.

The approval process involves:

Evaluation of the institution's technical and medical capacity.

Assessment of cellular preparation procedures.

Assessment of preservation and storage methods.

Evaluation of therapeutic indications.

Compliance with good medical practices.

Review by the Consultative Council for Human Organ Transplantation.

Informed consent from the patient before collection and administration.

The Ministry expressly connects these activities with Laws 16-98 and 28-13.

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Legal significance for international transfers: An overseas laboratory cannot assume that a Moroccan healthcare institution is automatically authorised to receive, process or administer imported stem-cell preparations. The receiving institution's regulatory status and the nature of the proposed treatment must be examined.

The circular specifically addresses autologous cellular therapies. It should not be treated as a complete import-export code for allogeneic stem cells, cord-blood products or industrially manufactured cellular medicines.

5. Biomedical Research and Stem Cell Importation: Law No. 28-13

Law No. 28-13, promulgated on 4 August 2015, regulates biomedical research involving human participants.

It is especially relevant where imported stem cells are intended for:

Clinical trials.

Experimental cellular treatments.

Gene-modified stem-cell research.

Regenerative medicine research.

Investigations involving manufactured cellular-therapy medicines.

Article 24: Research-site authorisation

Article 24 establishes requirements concerning the location and institutional capacity of biomedical research.

It provides that research involving industrially manufactured medicines for cellular therapy, gene therapy and xenogeneic cellular therapy can only be conducted in specified public healthcare establishments or research sites associated with university hospital centres.

Research sites must have appropriate human, material and technical resources and must be approved by the administration.

This is particularly important when stem cells cross international borders for research purposes. The importation of a biological preparation does not itself authorise its use in a clinical investigation.

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Consent and research ethics

Importing institutions should also establish:

The identity and eligibility of the donor.

The legal basis for collection.

The donor's informed consent.

The permitted research or therapeutic purpose.

The identity of the receiving institution.

The conditions governing further use of the cells.

Procedures for protecting confidential donor information.

6. Importation and Exportation of Stem Cells

The legal position depends on the biological nature and intended use of the material.

A. Importation of stem cells into Morocco

Importation may involve bone-marrow-derived cells, peripheral-blood stem cells, umbilical-cord-blood stem cells or laboratory-expanded cellular preparations.

The importing institution should determine whether the material is legally classified as human tissue, a cellular-therapy preparation, a blood-derived product or a medicinal product.

Where Law 16-98 applies, Articles 27 and 28 establish an administrative authorisation mechanism for imported human organs and tissues falling within its scope.

Where the 2019 cellular-therapy controls apply, the receiving centre must also satisfy the relevant approval requirements.

Practical compliance documentation should include:

Donor consent and collection records.

Medical indication and treatment protocol.

Origin and identity of the cellular material.

Donor screening and infectious-disease testing.

Laboratory processing and quality-control records.

Cell viability and sterility information.

Packaging and temperature-control records.

Transport and chain-of-custody documentation.

Receiving institution's authorisation.

Relevant administrative import permissions.

These are compliance measures derived from the applicable safety and traceability framework; they should not all be represented as a single statutory checklist expressly prescribed for every stem-cell shipment.

B. Exportation of stem cells from Morocco

Exportation raises similar concerns, especially where human tissues are transferred to foreign laboratories or transplantation centres.

Where the material is covered by Law 16-98, Articles 27 and 29 are particularly relevant.

The authorities must consider the statutory authorisation requirements, the recipient organisation and the applicable governmental arrangements.

Exporters should also consider:

Donor consent covering the proposed overseas transfer.

The legal status of the foreign receiving institution.

The permitted therapeutic or research purpose.

International transport and biosafety requirements.

Confidentiality and personal-data protection.

Restrictions on commercial transactions involving human biological material.

Return, destruction or secondary-use arrangements.

Important distinction: Article 29 expressly concerns human organs under Law 16-98. Its application to isolated stem-cell preparations depends on their legal classification and should not be assumed without examining the relevant facts.

7. Special Regulation of Reproductive Cells and Embryonic Materials

Law No. 47-14 of 2019, concerning medically assisted reproduction, creates a separate and particularly strict regime.

Article 30 provides that:

Exportation of embryos, gametes and germinal tissues abroad is prohibited.

Importation of embryos into Morocco is prohibited.

Importation of gametes and germinal tissues may be permitted through special administrative authorisation.

The authorisation must follow consultation with the relevant advisory commission.

Only authorised assisted-reproduction centres or healthcare establishments may obtain such import authorisation.

Authorisation is required for each proposed import operation.

Good-practice and traceability requirements must be respected.

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This distinction is important in stem-cell regulation.

For example, an embryonic stem-cell line is not automatically equivalent to an embryo, gamete or germinal tissue. The precise material and intended activity must be identified before applying Article 30.

The law should therefore not be interpreted as creating a blanket prohibition on importing every type of stem-cell preparation.

8. Pharmaceutical Regulation: Law No. 17-04

Law No. 17-04 establishes Morocco's Medicines and Pharmacy Code.

It becomes relevant where a stem-cell preparation qualifies as a medicinal product, particularly an industrially manufactured cellular therapy.

The regulatory questions include:

Whether the product requires marketing authorisation.

Whether a specific import authorisation is necessary.

Whether the importing organisation is legally qualified.

Whether manufacturing and quality standards are satisfied.

Whether the product is intended for clinical trials or treatment.

Whether export documentation is required.

The Moroccan Agency for Medicines and Health Products (AMMPS) published an import-export guideline on 9 May 2026.

The guideline addresses:

Importation of medicines with marketing authorisation.

Special import permissions for patients and emergencies.

Importation for clinical trials and registration.

Certificates of Free Sale.

Pharmaceutical Product Certificates for exports.

Traceability and product-quality requirements.

This guideline applies to medicinal products. It does not automatically establish that every human stem-cell sample is a medicine.

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9. Administrative Approvals for Stem Cell Transplantation

Morocco has issued specific administrative approvals for healthcare institutions undertaking autologous haematopoietic stem-cell transplantation.

Examples include:

These decisions demonstrate that stem-cell transplantation is subject to institutional approval and regulatory supervision.

They are administrative authorisations, not judicial precedents. They also do not independently establish permission to import or export every category of stem cells.

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10. Criminal Liability for Illegal Import and Export

Law No. 16-98 contains significant criminal provisions.

Article 40: Unauthorised importation and exportation

Article 40 provides for imprisonment of five to ten years for a person who imports or exports human organs without administrative authorisation.

Its application to a stem-cell shipment depends on whether the biological material falls within the law's statutory scope.

It would be legally incorrect to assume that every isolated stem-cell preparation automatically attracts this penalty.

Article 41: Liability of public officials

Article 41 establishes imprisonment of two to five years and a fine of MAD 20,000–50,000 for a public official who authorises an import or export operation involving a person, hospital or organisation that does not satisfy the statutory requirements.

Article 42: Professional restrictions

The law also provides for professional prohibitions in specified circumstances, including certain offences involving unauthorised importation and exportation.

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11. Case Laws and Judicial Principles

An important research qualification is necessary: I could not verify a published Moroccan court judgment directly deciding the legality of international stem-cell importation or exportation under Laws 16-98 or 28-13.

It is therefore more accurate to distinguish relevant Moroccan statutory and administrative precedents from comparative international judicial decisions.

Case 1: Evans v. United Kingdom (2007)

European Court of Human Rights · Grand Chamber · Application No. 6339/05 · Judgment of 10 April 2007

Facts:

The dispute concerned embryos created through in-vitro fertilisation. Following the withdrawal of consent by one genetic parent, the other parent sought permission to use the embryos.

Legal issue:

Whether restrictions governing the use and preservation of embryos violated the applicant's rights under Article 8 of the European Convention on Human Rights.

Decision:

The European Court found no violation of Article 8 in the circumstances and recognised the importance of the domestic legal framework governing consent to embryo use.

Relevance to Morocco:

The decision illustrates the importance of informed consent and the legal control of human reproductive biological material.

It is relevant by analogy to international transfers of reproductive materials, but it does not decide the import or export of ordinary stem-cell preparations.

Case 2: Parrillo v. Italy (2015)

European Court of Human Rights · Grand Chamber · Application No. 46470/11 · Judgment of 27 August 2015

Facts:

The applicant sought to donate embryos created through assisted reproduction to scientific research.

Italian legislation prohibited the proposed donation.

Legal issue:

Whether the restriction violated the right to respect for private life under Article 8.

Decision:

The Court found no violation of Article 8. It considered the ethical sensitivity of embryo research and the state's margin of appreciation in this field.

Relevance to Morocco:

The case provides comparative guidance concerning embryo research, human dignity and restrictions on the scientific use of reproductive biological materials.

It should not be confused with a judgment concerning adult stem-cell or haematopoietic-cell shipments.

Case 3: Costa and Pavan v. Italy (2012)

European Court of Human Rights · Application No. 54270/10 · Judgment of 28 August 2012

Facts:

The applicants challenged restrictions on preimplantation genetic diagnosis in connection with assisted reproduction.

Legal issue:

Whether the restrictions were compatible with Article 8 of the European Convention on Human Rights.

Decision:

The Court found a violation of Article 8 because of the inconsistency in the domestic legal framework.

Relevance to Morocco:

This decision provides comparative insight into reproductive autonomy, genetic information and consistency in biotechnology regulation.

It is particularly relevant when examining the relationship between Law No. 47-14 and the movement of reproductive biological materials.

These three decisions are comparative European authorities, not binding Moroccan judgments.

12. Data Protection and Confidentiality

Stem-cell transportation frequently involves sensitive personal and genetic information.

Examples include:

Donor identity.

Genetic profiles.

Medical history.

Family relationships.

Disease susceptibility.

Tissue compatibility.

Clinical treatment records.

Morocco's Law No. 09-08 regulates the processing of personal data.

International transfers of donor information must therefore be examined under applicable data-protection requirements.

Hospitals and laboratories should implement:

Confidentiality agreements.

Secure electronic records.

Donor-identification safeguards.

Access-control systems.

Appropriate transfer arrangements.

Retention and deletion policies.

Protection against unauthorised disclosure.

A lawful transfer of physical stem cells does not automatically make the transfer of associated genetic information lawful.

13. International Legal Framework

Morocco's regulatory approach should also be understood in the context of international standards.

These instruments and standards have different legal statuses. They should not all be treated as directly enforceable Moroccan import-export legislation.

14. Major Legal Challenges

A. Regulatory classification

A major difficulty is determining whether stem cells are human tissues, biological samples, cellular-therapy preparations or medicinal products.

Different classifications may trigger different authorisation procedures.

B. Cross-border donor consent

Consent obtained in another country may not necessarily satisfy every Moroccan requirement.

C. Quality and contamination

International transportation can expose cellular materials to contamination, temperature variations and loss of viability.

D. Commercial exploitation

The commercialisation of human biological materials raises questions about human dignity, donor rights and prohibited transactions.

E. Regulatory coordination

The Ministry of Health, AMMPS, customs authorities, healthcare institutions and research ethics bodies may have different responsibilities.

F. Jurisdictional conflicts

A stem-cell preparation may be lawfully collected in one country but subject to stricter transplantation or research restrictions in Morocco.

G. Accountability for defective materials

Where imported cells cause infection, injury or treatment failure, liability may involve the foreign supplier, transporting organisation, importing institution, treating physician or manufacturer, depending on the facts.

15. Recommendations for Strengthening Moroccan Regulation

Morocco could strengthen its stem-cell import-export framework through the following measures:

Establish a dedicated legal classification system for different stem-cell categories.

Introduce a transparent, shipment-specific authorisation procedure.

Establish a national registry of approved stem-cell laboratories.

Introduce standardised international chain-of-custody documentation.

Establish mandatory donor-consent and traceability requirements.

Strengthen cross-border cooperation between regulatory authorities.

Develop specialised inspection procedures for cellular-therapy shipments.

Establish clear liability rules for defective imported cellular products.

Improve supervision of private regenerative-medicine clinics.

Develop a national framework for international stem-cell research collaborations.

16. Conclusion

Morocco regulates stem-cell importation and exportation through a combination of human tissue transplantation legislation, biomedical research legislation, pharmaceutical regulation and administrative controls.

Law No. 16-98 is central to the import and export of human organs and tissues within its scope. Law No. 28-13 governs biomedical research involving human participants. The 2019 Ministry of Health circular establishes important institutional approval requirements for autologous cellular therapies. Law No. 47-14 imposes separate restrictions on embryos, gametes and germinal tissues.

The central legal challenge is distinguishing ordinary stem-cell preparations from regulated organs, tissues, reproductive materials and medicinal products.

A shipment's legality therefore depends on its biological classification, purpose, origin, receiving institution and applicable authorisations. Morocco's framework provides several important safeguards, but a dedicated, comprehensive cross-border stem-cell regulatory regime would improve legal certainty, international cooperation and patient protection.

Important Legal References

Law No. 16-98 on the donation, removal and transplantation of human organs and tissues.

Decree No. 2-01-1643 implementing Law No. 16-98.

Ministerial Order No. 2250-09 on good practices for the removal, transplantation, preservation and transportation of human organs and tissues.

Law No. 28-13 on the protection of persons participating in biomedical research.

Law No. 17-04 on the Medicines and Pharmacy Code.

Law No. 47-14 on medically assisted reproduction.

Law No. 09-08 on personal-data protection.

Ministry of Health circular announced on 6 June 2019 concerning cellular therapies.

AMMPS import-export guideline published on 9 May 2026.

Primary research sources:

Moroccan Ministry of Health – Medical Practice Regulations

Ministry of Health – Cellular Therapy Circular, 2019

Moroccan Law No. 16-98 – Consolidated Text

Moroccan Law No. 28-13 – Article 24

Moroccan Law No. 47-14 – Article 30

AMMPS – Import and Export Guideline, 2026

Academic note: This is a legal research overview, not confirmation that a particular stem-cell shipment has obtained the necessary permits. The applicable rules should be verified against the current official Arabic or French legislation and the specific classification of the cells.