Pharmaceutical establishment manufacturing pharmaceutical products (regulated activity)

Activity contents

• Pharmaceutical establishment manufacturing pharmaceutical products which include:
• Medicines;
• Medicinal chemicals;
• Galenic products;
• Raw materials for pharmaceutical use;
• Dietetic foods intended for special medical purposes;
• All other products necessary for human medicine (in accordance with the provisions of articles 207 and 208 of law no. 18-11 of July 2, 2018, relating to health).

Authorized accessory activities

• Distribution of products defined in the content of the activity, intended for wholesalers and communities.

Supervisory authority

MINISTRY IN CHARGE OF THE PHARMACEUTICAL INDUSTRY

Type of authorization: Approval

How to start this activity in Algeria

Official procedure, ordering of steps, and realistic timelines

1. Step 1: Obtain the licence from MINISTRY IN CHARGE OF THE PHARMACEUTICAL INDUSTRY

   The activity "Pharmaceutical establishment manufacturing pharmaceutical products (regulated activity)" is regulated. You must first build an accreditation file with the supervisory authority (articles, qualification proof, premises eligibility) before any CNRC registration.

   2 to 6 weeks

2. Step 2: Company incorporation (LLC, single-member LLC or sole proprietorship)

   Once you hold the licence, sign the articles at the notary, declare the share capital, then request the company name + Trade Register at CNRC. For a heavy licence, a SARL/EURL is usually required over the auto-entrepreneur regime.

   7 to 10 days

3. Step 3: Tax and social registrations

   With your trade register in hand, obtain the NIF (tax ID), NIS (social security ID for the manager), CNAS affiliation for employees, and the tax card. Your activity "Pharmaceutical establishment manufacturing pharmaceutical products (regulated activity)" can then start lawfully.

   3 to 7 days

Legal references

• Executive Decree No. 21-82 of February 23, 2021, Relating to pharmaceutical establishments and the conditions of their approval.

Frequently asked questions