Nigeria: Legal Framework For Carrying On Pharmaceutical Business In Nigeria

Last Updated: 24 May 2017
Article by Ugochi Igwe

All aspects of pharmacy practice in Nigeria are regulated by the Pharmacists Council of Nigeria Act (1992 No. 91) ("the Act"). The Act provides for the registration of pharmaceutical premises in Nigeria before commencement of a pharmaceutical business. The Act establishes the Pharmacist Council of Nigeria ("the Council"), as the body with the sole responsibility of registering, monitoring, regulating and controlling all aspects of pharmaceutical practice in Nigeria. The Council is in charge of the inspection and registration of pharmaceutical retail, wholesale and manufacturing premises. The Council in exercise of the powers conferred upon it by the Act, made regulations guiding the registration of pharmaceutical premises as follows;

  1. Registration of Pharmaceutical Premises
    1. The Registration of Pharmaceutical Premises Regulations, 2005 ("the Registration Regulation"), provides for registration of new pharmaceutical premises and renewal of old premises;
    2. It provides that where the premises sought to be registered is a retail pharmacy; the company shall be wholly owed by a registered pharmacist or in partnership with other registered pharmacist.
    3. For a pharmaceutical premises involved in wholesale, distribution and importation of drugs, poisons and devices, there shall be at least one registered pharmacist on the Board of Directors of the Company. The business shall be carried out under the direct personal control and management of a Superintendent Pharmacist.
    4. Where the primary object of the company is pharmaceutical manufacturing, there shall be at least one registered pharmacist on the Board of Directors of the Company; the business shall be carried out under the direct personal control and management of a Superintendent Pharmacist.
  1. Inspection, Location and Structure of Pharmaceutical Premises

The Inspection, Location and Structure of Pharmaceutical Premises Regulations, 2005 ("the Inspection Regulation") establishes a Pharmaceutical Inspectorate Division which consist of registered Pharmacists designated as pharmaceutical inspectors, appointed by the Council to enter into pharmaceutical premises and inspect to ensure due compliance with the provisions of the Regulation.

  1. The Inspection Regulation provides for the location of pharmaceutical premises. It shall not be located in motor parks, environment close to a location where commercial activities and enterprise are standing and growing; market places including kiosks and road side retail.
  2. It provides that any pharmaceutical premises surrounded or covered completely by a growing market or standing close to it shall be moved to another suitable location two years after formal notification to do so by the Council.
  3. Pharmaceutical premises within a shopping centre shall not be more than three and they shall be well spaced out.
  4. Pharmaceutical premises shall be sited not less than two hundred meters from each other.

Pharmaceutical practice in Nigeria is also regulated by the National Agency for Food and Drug Administration Act. The Act establishes the National Agency for Food and Drug Administration ("NAFDAC"). The Agency has a complementary role to play in the registration of pharmaceutical premises. It does the following;

  1. The Agency is in charge of evaluation and registration of Pharmaceutical products;
  2. Post market surveillance and risk analysis of products;
  3. Control of product import and export; and
  4. Regulation of product promotion and public education.
  1. Registration of Retail, Distribution and Importation Premises

For the registration of a new pharmaceutical retail, distribution or importation premises, the following documents shall be submitted to the Registrar, of the Council, through the Director of Pharmaceutical Services of the State where the premises is to be operated;

  1. An application letter (in the company's letter headed paper) to register premises;
  2. A duly completed Form B (PCN's Application Form for the Registration of Premises);
  3. A photocopy of the Annual License to practise or an application for the retention of name on the Pharmaceutical Register (Form J);
  4. The prescribed inspection and registration fees, in bank draft, payable to the Council;
  5. A photocopy of the letter of resignation from a previous employment (if applicable);
  6. The Letter of Acceptance of Resignation (if applicable);
  7. The Letter of Appointment in the new premises (where applicable);
  8. The Legal Agreement between the Superintendent Pharmacist and his employer (where applicable);
  9. The Company's Certificate of Incorporation (Evidence of registration pf business name is acceptable in respect of a Pharmacist-owned retail premises);
  10. Certified copy of the company's Articles and Memorandum of Association;
  11. Certified copy of Particulars of the company's Directors as issued by the Corporate Affairs Commission(CAC);
  12. A photocopy of the NYSC Discharge or Exemption Certificate (where applicable);
  13. A Letter of Undertaking by the Superintendent Pharmacist to the effect that he has only one pharmaceutical job;
  14. A Letter of Undertaking by the Managing Director of the company to the effect that all pharmaceutical businesses would be under the direct, personal, control and management of the Superintendent of the Pharmacist;
  15. A Pharmacists Inter-state Movement Form (where applicable), duly completed;
  16. Evidence of a Pharmacist on the Board of Directors; and
  17. The Current Annual License of the Pharmacist Director.

On the receipt of the above named documents, inspection of the pharmaceutical premises shall be carried out to ensure compliance with the requirements for the registration of such premises.

  1. Registration of Pharmaceutical Manufacturing Premises

The requirements for the registration of pharmaceutical retail, distribution and importation outfits are also required for manufacturing premises, including the following:

  1. The list of products to be manufactured;
  2. An Organogram;
  3. The list of staff qualification and duties;
  4. The Factory layout;
  5. The production flow-chart;
  6. The list of equipment in the production and quality control departments;
  7. The Source of water and water treatment facilities;
  8. The Water analysis report of raw and treated water;
  9. The list and source of suppliers of raw materials and packaging materials;
  10. Standard Operating Procedures (SOP);
  11. Standard Cleaning Procedures; and
  12. Payment of the Inspection Fee – in bank draft of N130, 000.00 payable to the Pharmacists Council of Nigeria.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Ugochi Igwe
 
In association with
Related Topics
 
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions