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Medication, Cosmetic, and Vitamin Registration in Egypt

Andersen in Egypt offers comprehensive legal and regulatory support for Medication, Cosmetic, and Vitamin Registration in Egypt. With deep knowledge of local regulations and direct engagement with authorities like the Egyptian Drug Authority (EDA) و National Food Safety Authority (NFSA), we guide clients through product classification, dossier preparation, submission, and compliance. From pharmaceuticals to cosmetics and supplements, we ensure efficient, compliant market entry in Egypt.

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Medication, Cosmetic, and Vitamin Registration in Egypt​

الإطار التنظيمي

Medications in Egypt are governed by EDA through its Central Administration for Pharmaceutical Products (CAPA). This body is responsible for overseeing licensing, ensuring safety and efficacy, and maintaining quality control. To gain approval under the Medication, Cosmetic, and Vitamin Registration in Egypt framework, medications must comply with EDA guidelines, which include submitting a full registration dossier, conducting stability studies, and fulfilling pharmacovigilance obligations.

Cosmetics require registration in accordance with specific regulations that involve commercial registration, legalized contracts, a technical dossier, labeling review, and final approval. As part of Medication, Cosmetic, and Vitamin Registration in Egypt, cosmetic products are reviewed based on classification and functionality. Approval is granted by either CAPA or the NFSA.

Vitamins, including food supplements and dietary supplements, fall under the jurisdiction of the NFSA. However, those with higher doses that are categorized as “complementary pharmaceuticals” must be registered with the EDA using the White List mechanism, in line with procedures defined in Medication, Cosmetic, and Vitamin Registration in Egypt.
Medication, Cosmetic, and Vitamin Registration in Egypt​

Pharmaceutical Product Registration Services

Product Registration Services
Regulatory Classification

Regulatory Classification

  • Regulatory classification and roadmap planning
  • Guidance across product categories (medication, cosmetics, vitamins)
  • Compliance with EDA and NFSA frameworks
Gap Analysis

Gap Analysis

  • Gap analysis across EDA and NFSA requirements
  • Technical documentation and submission strategy
  • Risk mitigation and registration feasibility
Dossier Preparation

Dossier Preparation & Submission

  • Preparation and submission of registration dossiers
  • Labeling, quality, stability reports, and CPP
  • Pricing documentation and supporting files
Regulatory Liaison

Regulatory Liaison

  • Liaison with EDA and NFSA technical committees
  • Follow-up on pending requests and clarifications
  • Representation during scientific or pricing reviews
Post-Approval Maintenance

Post-Approval Maintenance

  • Product renewals and variation submissions
  • Support for packaging, formulation, and labeling updates
  • Handling of product withdrawals and changes
Regulatory Monitoring

Regulatory Monitoring

  • Continuous updates on EDA and NFSA regulation changes
  • Compliance alerts and documentation revisions
  • Market entry planning based on policy trends

Medication, Cosmetic, and Vitamin Registration Process in Egypt

Medication, Cosmetic, and Vitamin Registration in Egypt

Medication Registration (Pharmaceuticals)

  1. To register medicine in Egypt, applicants must create an account through the EDA portal for pharmaceutical product registration.
  2. A request to schedule the medicine register submission is sent to CAPA.
  3. Product registration requires technical documentation, safety studies, and pricing data.
  4. Applications undergo three evaluation tracks depending on dossier strength and country of origin.
  5. Drug registration mandates stability and bioequivalence studies before final approval is granted through pharmaceutical product registration.
  6. Marketing authorization follows full technical and pharmacovigilance review.
  7. Products listed in the medicine register must be renewed every 10 years with updated documentation.

Cosmetic Registration (Notification Process)

  1. Cosmetic registration is managed by EDA through the EgyCosm system, where companies can register makeup and skincare items.
  2. To register makeup products, a file must be submitted including formula, labeling, and a Free Sale Certificate.
  3. Cosmetic registration numbers are usually issued within 3–10 business days depending on the track chosen.
  4. Each product registration for cosmetics is valid for 10 years, with renewals required before expiration.

Vitamin & Dietary Supplement Registration

  1. Product registration for vitamins is split between NFSA and EDA based on whether pharmaceutical product registration is required due to health claims.
  2. Supplements without therapeutic claims follow the NFSA process, while high-dose or medical claim products go through drug registration.
  3. A complete file must include safety, efficacy, labeling, and justification of claims.

Summary Comparison

Product Type Regulator Key Steps Typical Timeframe
Medications EDA / CAPA Medicine register → product registration → evaluation → drug registration Track A: ~1 month, B: ~2 months, C: ~3 months
Cosmetics EDA Cosmetic registration → submit file → register makeup → approval 3–10 working days
Vitamins & Supplements NFSA / EDA Determine authority → submit for product registration or pharmaceutical registration Dependent on track (typically 1–3 months)

Pharmaceutical Product Registration Documents

Document Requirements
Admin Documents
Application form, CPP, license copy, agent authorization.
Summaries
Overviews of quality, clinical, and non-clinical information.
Quality Dossier
Composition, manufacturing, GMP certificate, stability data.
Clinical Data
Bioequivalence studies or full clinical trials.
Authorization Letter
From License Holder, notarized by Chamber of Commerce & Egyptian Embassy.
Relationship Letter
If manufacturer ≠ license holder, notarized letter required.
Free Sale Certificate
Notarized certificate of marketing from country of origin.
Factory License
Official factory license of the product manufacturer.
Product Composition
Full INCI list with percentage and function of each ingredient.
Shelf Life Certificate
Signed certificate indicating shelf life from date of manufacturing.
Mock-up (Design/Layout)
Outer and inner package artwork in Arabic and English.
Certificate of Analysis
Lab-issued document verifying physical/chemical parameters.
Nutrition Facts
Complete vitamin/mineral breakdown with dosage values.
Product Label
Arabic/English label with usage, warnings, storage, etc.
Health Claims
If present, must be justified with scientific references.
Classification Form
Determines whether submission is to NFSA or EDA.

Frequently Asked Questions​

Medication, Cosmetic, and Vitamin Registration in Egypt – FAQ

Register Medication:

Why is it necessary to register medication in Egypt?

To register medication in Egypt, pharmaceutical companies must comply with national safety, efficacy, and quality standards. The EDA oversees pharmaceutical product registration to ensure safe and effective treatments reach the market.

What is the expected timeline to register medication?

The timeline to register medication varies by track. Fast-track drug registration may take a few months, while full pharmaceutical registration can extend up to 4 years depending on documentation and technical review.

Who is responsible for managing the medicine register in Egypt?

The Egyptian Drug Authority (EDA), through its CAPA division, is responsible for the medicine register, product evaluation, and pharmaceutical product registration in Egypt.

Register Cosmetic:

Why is cosmetic registration required in Egypt?

To register cosmetic products in Egypt, companies must follow guidelines set by the EDA and sometimes NFSA. This ensures consumer safety and accurate labeling for all products that register makeup, skincare, or personal care items.

How long does it take to register cosmetic products?

The time to register cosmetic products ranges from 3 to 10 working days depending on the submission track and completeness of the cosmetic registration dossier.

Register Vitamin:

What is required to register vitamin supplements in Egypt?

To register vitamin products, companies must first determine whether the supplement falls under NFSA or requires pharmaceutical product registration through the EDA. Classification is based on dosage and health claims.

Who oversees the process to register vitamin and dietary supplements?

The National Food Safety Authority (NFSA) typically oversees vitamin registration unless the product qualifies as a complementary pharmaceutical, in which case the EDA manages the pharmaceutical registration process.

What documents are needed for product registration in Egypt?

Required documents include product specs, composition, intended use, GMP/ISO certification, free sale certificate, Arabic/English labeling, and scientific justification. These apply to both pharmaceutical product registration and cosmetic registration.

How do I submit my pharmaceutical or cosmetic registration file?

Submissions are made via the EDA’s Shababeek system for pharmaceutical product registration or the EgyCosm platform for cosmetic registration. Fees apply and physical samples may be requested after dossier review.

Are there fees for drug registration, cosmetic registration, and product submission?

Yes, registration fees vary. Pharmaceutical product registration typically ranges from ~EGP 10,000 to 20,000. Cosmetic registration and register makeup processes have separate fee structures based on review category and dossier complexity.

Can reliance pathways speed up pharmaceutical registration?

Yes. Products already approved by regulatory bodies like the FDA, EMA, or WHO may qualify for reliance pathways, significantly accelerating pharmaceutical registration and drug registration in Egypt.

What is a pre-submission assessment in drug registration?

The EDA’s technical committee can conduct a preliminary assessment of your dossier before full pharmaceutical product registration. This reduces the risk of rejection during the final application stage.

How long does technical evaluation take for pharmaceutical registration?

After dossier acceptance, the technical review for pharmaceutical registration may take up to 60 days. Pricing and classification committees may extend the drug registration timeline by another 30 days or more.

How does the cosmetic registration and register makeup process work?

Cosmetics are “notified” through the EgyCosm system rather than fully registered. To register makeup or personal care items, submit artwork, ingredients, and shelf life data. Approval is granted in as little as 3 working days (fast track) or up to 10 days.

Are all products that register makeup subject to cosmetic registration rules?

Yes, products that register makeup or skincare must comply with cosmetic registration regulations. However, some perfume or decorative items may be exempt from Certificate of Inspection under ECAP updates.

What claims are not allowed in cosmetic registration?

Claims such as slimming, anti-cellulite, therapeutic effect, or fast action are banned in cosmetic registration. These are classified under drug registration or pharmaceutical categories and cannot be used for registered makeup or skin products.

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