Regulations Governing Registration of Medicinal Products  
 
 
Doc. Ref. No.: DFAR /HMDAR /TRG /001 Rev_ 3   
  
 
 
 
 
 
 
 
 
 
 
REGULATIONS GOVERNING REGISTRATION OF 
MEDICINAL PRODUCTS  
(Rwanda FDA Law No 003/2018 of 09/02/2018, Article 9) 
 
 Regulations Governing Registration of Medicinal Products  
 
 
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 REGULATION DEVELOPMENT HISTORY  
 
DRAFT ZERO BY COUNSULTANTS  09/09/ 2019  
ADOPTION BY RWANDA FDA  04/02/ 2020  
STAKEHOLDERS CONSULTATI ON 31/08/2022  
ADOPTION OF STAKEHOLDERS`COMMENTS  31/09/2022  
DATE FOR COMING INTO EFFECT  28/09/2022  
 
Document Revision History  
 
Date of revision  Revision number  Changes made and/or reasons for revision  
20/04/2020  0 First Issue  
08/06/2021  1 1. The Article o n reliance is included  
2. The article on authorization for emergency 
use included  
3. The article on Donation of medicinal 
products included  
4. Interline is changed from 1.5 to 1.15 as per 
SOP on internal document control.   
07/10/2021  2 1. Article 16 on Authorizati on for Emergency 
Use was revised  
2. Article 33 on Exemption revised to include a 
statement on Authorisation for Emergency 
Use 
3. Article 34 on  Advisory or Scientific 
Committee included  
4. Inclusion of French and Kinyarwanda as 
application language  
5. Editorial changes  
09/09/2022  3 1. Formulate the article 15  on conditional 
registration of medicinal product by merging 
the article 15  on conditional registration of 
medicinal products  and article 16  on 
Authorization for Emergency Use  
 
2. Editorial changes  
  Regulations Governing Registration of Medicinal Products  
 
 
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ADOPTION AND APPR OVAL OF THE REGULATIONS  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  Regulations Governing Registration of Medicinal Products  
 
 
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ARRANGEMENT OF THE REGULATIONS   
REGULATION DEVELOPME NT HISTORY  ................................ ................................ .........  2 
DOCUMENT REVISION HISTORY  ................................ ................................ ................................ ... 2 
ADOPTION AND APPROVA L OF THE REGULATIONS ................................ ....................  3 
ARR ANGEMENT OF THE REGU LATIONS  ................................ ................................ ..........  4 
CHAPTER ONE: GENERAL  PROVISIONS  ................................ ................................ ...........  6 
ARTICLE ONE: PURPOSE OF THE REGULATIONS  ................................ ................................ ............  6 
ARTICLE 2: SCOPE  ................................ ................................ ................................ ........................  6 
ARTICLE 3: CITATION  ................................ ................................ ................................ ...................  6 
ARTICLE 4: DEFINITIONS  ................................ ................................ ................................ ..............  6 
CHAPTER II: ASSESSME NT AND REGISTRATION OF MEDICINAL PRODUCT  ...... 7 
ARTICLE 5: APPLICATION FOR REGIS TRATION OF MEDICINAL  PRODUCTS  ................................ ...... 7 
ARTICLE 6: APPLICATION REQUIREME NTS FOR REGISTRATION  OF MEDICINAL PRODUC T ..............  8 
ARTICLE 7: DATA REQUIREMENTS FOR  REGISTRATION OF A M EDICINAL PRODUCT  .......................  8 
ARTICLE 8: LANGUAGE  ................................ ................................ ................................ ................  8 
ARTICLE 9: AUTHENTICITY OF DOCUM ENTS  ................................ ................................ .................  8 
ARTICLE 10: ACCOU NTABILITY OF THE APP LICANT AND MARKETING  AUTHORIZATION HOLDE R .. 8 
ARTICLE 11: SAFE CUSTODY AND CONF IDENTIALITY OF INFOR MATION  ................................ ........  9 
ARTICLE 12: ASSESSMENT PROCESS OF  MEDICINAL PRODUCTS  ................................ ....................  9 
ARTICLE 13: GOOD MANUFACTURING PRACTICES AND GOOD CLINICAL PRACTICES .................  10 
ARTICLE  14: REGISTRATION OF MEDIC INAL PRODUCTS  ................................ ..............................  10 
ARTICLE 15: CONDITIONAL AUTHORIZA TION OF MEDICINAL PR ODUCT  ................................ ...... 10 
ARTICLE 16: RELIANCE  ................................ ................................ ................................ ..............  11 
ARTICLE 17: APPROVAL OF MEDICINAL  PRODUCT  ................................ ................................ ...... 11 
ARTICLE 18: PUBLICATION OF A REGI STERED MEDICINAL PRO DUCT  ................................ ...........  11 
ARTICLE 19: VALIDITY OF REGISTRATION CERTIFICATE  ................................ ............................  12 
ARTICLE 20: APPLICATION FOR VARIA TION OF A REGISTERED  MEDICINAL PRODUCT  ..................  12 
ARTICLE 21: RETENTION OF MEDICINA L PRODUCT ON THE REG ISTER  ................................ .........  12 
ARTICLE 22: TIMEFRAMES FOR APPLICATION FOR RENEW AL OF REGISTRATION C ERTIFICATE  .... 12 
ARTICLE 23: SUSPENSION OF REGISTE RED MEDICINAL PRODUC T ................................ ................  13 
ARTICLE 24: NOTICE OF SUSPENSION  ................................ ................................ .........................  13 
ARTICLE 25: SUSPENSION OR CANCELL ATION OF REGISTRATIO N WITHOUT NOTICE  ....................  13 
ARTICLE 26: RESTORATION OF A CANC ELLED OR SUSPENDED R EGISTERED MEDICINAL PRODUCT
 ................................ ................................ ................................ ................................ ...................  14 
ARTICLE 27: REFUSAL TO GRANT MARK ETING AUTHORISATION  ................................ .................  14 
ARTICLE 28: CANCELLATION OR REVOC ATION OF MARKETING A UTHORISATION  ........................  15 
ARTICLE 29: LABELLING AND PACKAGE INSERT ................................ ................................ .........  15 
ARTICLE 30: DONATION OF MEDICINAL  PRODUCTS  ................................ ................................ .... 15  Regulations Governing Registration of Medicinal Products  
 
 
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 CHAPT ER III: RESTRICTION FOR SALE OF UNREGIST ERED MEDICINAL 
PRODUCT  ................................ ................................ ................................ ................................ ... 15 
ARTICLE 31: PROHIBITIONS  ................................ ................................ ................................ ........  15 
ARTICLE 32: EXEMPTION  ................................ ................................ ................................ ............  16 
CHAPTER IV: MISCELLE NIOUS AND FINAL PROV ISIONS  ................................ ........  16 
ARTICLE 33: ADVISORY OR SCIENTIFIC COMMITTEE  ................................ ................................ .. 16 
ARTICLE 34: APPEALS AND REVIEW  ................................ ................................ ...........................  17 
ARTICLE 35: POWER TO ISSUE GUIDEL INES ................................ ................................ .................  17 
ARTICLE 36: ADMNISTRATIVE SANCTIONS  ................................ ................................ .................  17 
ARTICLE 37: COMMENCEMENT AND REPE ALING  ................................ ................................ .........  17 
  Regulations Governing Registration of Medicinal Products  
 
 
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CHAPTER ONE : GENERAL PROVISIONS  
 
Article One: The P urpose of the  Regulations  
 
The purpose of these Regulations i s to put in place a legal framework to ensure effective and 
efficient registration of medicinal products, and to provide an open, transparent and non -
discriminatory process for the registration of all medinal products  regulated by Rwanda Food 
and Drugs aut hroity . 
 
Article 2 : Scope  
 
These regulations cover human and veterinary medicinal products, vaccines and biological 
products for human and animal use, herbal medicinal products, disinfectant and antiseptics 
excluding cosmetics as well as laboratory and ho usehold chemicals.  The regulations apply to 
all medicinal products to be registered in Rwanda.  
 
Article 3: Citation  
 
These regulations may be cited as “ Rwanda FDA Regulations Governing the Registration of 
medicinal products”.  
  
Article 4 : Definitions  
 
In these regulations, unless the context otherwise requires:  
 
1.  “Applicant ” means a person who applies for registration of a medicinal product 
to Rwanda FDA, who must be the owner of the product. He may be a manufacturer or a 
person to whose order and specifi cations, the product is manufactured. After the product 
is registered, the applicant shall be the “Marketing Authorisation Holder”.  
2. “Approve ” or “approval” means official consent by the Authority as an 
acceptance of a medicinal product or practices related  to that medicinal product to be 
available on the market in Rwanda  
3. “Authority ” means the Rwanda Food and Drugs Authority or its acronym 
“Rwanda FDA”, established under the article 2 of the Law No. 003/2018 of 09/02/2018.  
4.  “Certificate of registration ” mean s a certificate issued by the authority after its 
approval to market and sell a product in Country;  
5. “Composition ” means the ingredients of which the product consists, proportions, 
degree of strength, quality and purity in which those ingredients are conta ined;   Regulations Governing Registration of Medicinal Products  
 
 
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 6. “Emergency circumstances ” means situations that occur when the country is 
faced with disasters, pandemics, war and any other national public health emergency 
declared by the Ministry of Health  or Ministry of Agriculture and Animal Resources ; 
7. “Good Ma nufacturing Practice " or its acronym “ GMP ” is that part of quality 
assurance which ensures that products are consistently produced and controlled to the 
quality standards appropriate to their intended use and as required by the Authority;  
8. “Label ” means any  tag, brand, mark, pictorial or other descriptive matter, written, 
printed stencilled, marked, embossed or impressed on or attached to a container of any 
medicinal product;  
9. “Manufacture ” means all operations that involve preparation, processing, filling 
transforming, packaging, and repackaging and labelling of medicinal products;  
10. “Manufacturer ” means a person or a firm that is engaged in the manufacture of 
medicinal products;  
11.  “Marketing authorization ” Means approval from the authority necessary to 
market and sell a pr oduct in Country  
12. “Medicinal product”  means any substance, or mixture of substances 
manufactured, sold, or presented as capable of preventing, treating human or animal 
diseases and any other substance intended for administration to a human bein g or an 
animal in order to diagnose diseases, restore, correct or carry out modification of organic 
or mental functions. It also means products used in disinfecting premises in which food 
and drugs are manufactured, prepared or stored, for cleaning hospita ls, equipment and 
farmhouses. It does not include medical devices or their components, parts or accessories.  
13. “ Unapproved product” means any regulated product marketed without prior 
approval by the Authority  
14. “Unmet medical needs ” means a  condition for whic h there exists no satisfactory 
method of diagnosis, prevention or treatment authorised in Rwanda  or, even if such a 
method exists, in relation to which the medicinal product concerned will be of major 
therapeutic advantage to those affected.  
 
CHAPTER II: A SSESSMENT AND REGISTRATION OF MEDICINAL PRODUCT  
 
Article 5 : Application for registration of medicinal products  
 
All medicinal products shall be registered by the Authority before they are placed on Rwanda 
market.  A person who intends to manufacture, sell, distribute , import or export a medicinal 
product shall  ensure it is done in compli ance with th e provisions of this regulations  
 
An application for registration of medicinal product shall be made to the  Authority in writing by 
the Marketing authorization h older, the manufacturer or Local Technical Representative.   Regulations Governing Registration of Medicinal Products  
 
 
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 Article 6 : Application requirements for registration of medicinal product  
 
Application for registration of medicinal product shall be made in hard or electronic copies as 
detailed in relevant Guide lines.   
 
A separate and complete application for registration of products shall be submitted for each 
medicinal product with different active ingredients, strengths, and dosage forms, site of 
manufacture or proprietary names.  
 
Notwithstanding the requireme nt stated above , all parenteral preparations in different pack sizes 
shall require separate applications  as provided for under the Guidelines.  
 
Article 7 : Data requirements for registration of a medicinal product  
 
All applications for registration of medic inal products shall comply with the technical 
requirements as determined by the Authority i n relevant  Guidelines  and shall be accompanied by 
data to demonstrate quality, safety and efficacy.  
 
Article 8 : Language   
 
All applications and supporting documents  shall be made in English, French or Kinyarwanda. 
Where some documents are submitted in a language different from English, French or 
Kinyarwanda , the applicant shall submit  translated copies to expedite the review process.  
 
Article 9 : Authenticity of docum ents 
 
Any document submitted to the Authority shall be authentic when approved by the applicant or 
by the authorized person.  
The Authority may reject an application for registration of medicinal product if it is satisfied that 
the submitted documents are n ot authentic or int egrity of data is questionable.  
 
Article 10 : Accountability of the applicant and marketing authoriz ation holder  
 
The applicant shall be accountable for  all information supplied in support of his/her application 
for registration of the product and variations thereof. The marketing authorization holder shall be 
accountable for:  
 
a. manufacturing the product in compliance with the specifications approved according to 
provisions of these Regulations;   Regulations Governing Registration of Medicinal Products  
 
 
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 b. updating, where  necessary, summary of produc t characteristics and package inserts for 
the purpose of enabling a correct and safe use of the product;  
 
c. communicating the variations to the Authority within the framework of the relevant 
provisions of the guidelines;  
 
d. providing responses to the issues ra isedby the Authority, in relation to a registered 
product;  
 
e. to carry out pharmacovigilance to monitor the safety of the product in the market and 
provide safety update reports to the Authority;  
 
f.   ensuring that the product continues to comply with the saf ety, efficacy and quality 
requirements prescribed  in the Law and Regulations.  
 
Article 11 : Safe custody and confidentiality of information  
 
The Authority shall ensure safe custody of information related to the registration of medicinal 
products submitted b y applicants.  
 
All information submitted shall be treated confidential and shall not be disclosed to any third 
party without a written consent of the applicant.  
 
Article 12 : Assessment process of medicinal products  
 
The Authority shall, upon being  satisfi ed by the application, conduct assessment to verify the 
compliance with safety, quality and efficacy requirements through full or abridged assessment 
procedures.  
a. The Authority may, during the assessment of the product, require the applicant to 
submit addit ional samples, documents, information, data or clarification to support the 
application for registration.  
 
b. Where the Authority requires additional samples, documents, information, and data and 
or clarification pursuant to paragraph c of this Article , the p rocessing of the application 
shall not proceed until the applicant makes  the additional  submission.  
 
c. Where the applicant fails to submit requested information according to paragraph  b of 
this Article , within the period of ninety (90) days from the date of request, the 
application shall be considered withdrawn.   Regulations Governing Registration of Medicinal Products  
 
 
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 d. Pursuant to the requirements of parapgraph  c of this Article , the applicant may by 
giving reasons in writing request for extension of time for submission of additional 
samples, documents, information,  data and or clarification requested by the Authority.  
 
e.  If the applicant fails to provide satisfactory responses  to the requested information 
according to paragraph b of this Article for a fourth time, the application shall be 
rejected . 
 
f.  An application w ithdrawn pursuant to paragraph c and an application rejected  pursuant 
to paragraph e of this A rticle shall only be considered for registration upon submission 
of a new application as per the req uirements of these Regulations.  
 
Article 13 : Good Manufacturin g Practices and Good Clinical Practices  
 
During the assessment of medicinal product, the Authority shall as it may deem necessary 
conduct announced on-site inspection or an announced inspection of the non -clinical studies, 
clinical trials, bio -studies and production site inspection to confirm the authenticity, precision 
and integrity of i nformation and data submitted.  
 
Article 14 : Registration of medicinal products  
 
The Authority shall issue a certificate of registration of medicinal products only if:  
 
a. The medicinal product dossier is assessed and product found to have fulfil led the  
requirements of safety, quality and efficacy ,  
b. The manufacturing site of the medicinal product is compliant to th e Good Manufacturing 
Practices , 
c.  Medicinal product fulfils the r equirements of laboratory quality tests . 
 
Article 15 : Conditional authorization of medicinal product  
 
The Authority, in duly justified cases  may grant  conditional marketing authorization  for 
medicinal products intended for the treatment, prevention or med ical diagnosis of seriously 
debilitating or life -threatening diseases , to meet unm et medical needs of patients  and animals as 
prescribed by comp etent medical authority within the country  
 
The power to grant an authorisation subject to conditions may be ex ercised only ; 
1. In emergency circumstances; and   Regulations Governing Registration of Medicinal Products  
 
 
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 2. When the applicant can show that he is unable to provide comprehensive data on the 
efficacy and safety of the medicinal prodct under normal conditions of use.  
 
The Authority may issue the authorization for emer gency use when a national public health 
and/or animal health emergency has been declared by the compet ent institutions . The emergency 
use authorization may also be granted for an unregistered medicinal product, or an unapproved 
use of a registered  medicina l product for public health interest and/or animal health interest  
 
Conditional marketing a uthorisation for such medicinal products may be granted prior to the 
submission of comprehensive pre-clinical, clinical or pharmaceutical data provided that the 
bene fit of the immediate availability outweighs the risks . The applicant shall be able to provide 
comprehensive data after authorization.  
 
Article 16: Reliance  
 
The Authority may rely on regulatory decisions from regional, international and other Stringent 
Regulatory  Authorities ’ decisions in regard to product market authorization when it deems 
necessary . 
 
Article 1 7: Approval of medicinal product   
 
Upon approval of registration of medicinal product, the Authority shall:  
 
a. enter in the register the prescribed p articulars of the medicinal product , 
 
b. allocate a registration number to the medicinal product , 
 
c. issue to the applicant  a certificate of full or conditional registration as per prescribed 
format.  
Article 1 8: Publication of a registered medicinal product  
 
The Authority shall publish a list of registered medicinal products on the authority’s website 
specifying the registration number, name under which the product is registered (brand and 
International Non Proprietary Name), Dosage form, Product strength, name and country of the 
marketing authorization holder, name and country of manufacturer, Local technical 
representative, and expiry date of the registration certificate.  
  Regulations Governing Registration of Medicinal Products  
 
 
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 Article 19: Validity of Registration  Certificate  
A certificate of full registration issue d under Article 18 shall, unless earlier suspended or 
revoked, and subject to payment of prescribed annual retention fees, be valid for a period of five 
(5) years from the date of issuance and may thereafter be renewed.  
 
Notwithstanding the provision in first paragraph of this Article , a certificate of conditional 
registration shall be valid for a period specified in the certificate and that period sha ll not exceed 
three (3) years.  
 
Article 20: Application for variation of a registered medicinal product  
 
Any variation to registered medicinal  product information shall be notified in writing to the 
Authority through an application in the approved format.  
 
An application for variation shall be submitted as per the requirements set out in the relevant 
Guideline s for Variation of Registered medicinal products in f orce at the time of submission.  
 
A distinction shall be made between major and minor variations in accordance with the relevant 
Guidelines for Variation of Registered medicinal products and there shall b e a distinction in the 
payment of applicable fees.  
 
Article 21: Retention of medicinal product on the register  
 
The registered medicinal product is retained on the register a nnually after payment of fees.  
 
Application for retention on the register shall b e submitted one  (1) month before the due date.  
 
The medicinal product shall be removed from the register if application and payment of fees is 
not effected as stated in the first and second paragraphs of this A rticle.  
 
Article 2 2: Timeframes for Applicatio n for renewal of registration certificate   
 
Application for renewal of registration shall be made to the Authority at least ninety (90) 
calendar days before its expiry.  A grace period for renewal shall extend to ninety (90) days after 
the specified expiry date.  
Failure to renew  the marketing authoriz ation within the grace period, the applicat ion shall be 
considered as new  . 
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 The application shall be in the prescribed format as per Rwanda FDA guidance for renewal of 
registration of medicinal products .  
 
Article 2 3: Suspension of registered medicinal product  
 
The Authority may suspend registered medicinal product if it is satisfied that:  
a. A registered medicinal product has been advertised in manner which is false or 
misleading or does not comply with the provis ions of the Laws and Regulations currently 
enforced by the Authority;  
b. The marketing authorization holder has contravened these Regulations or any other 
provision of the Laws;  
c. The marketing authorisation holder made a false or misleading statement or 
misrep resentation in the application;  
d. the marketing authorisation holder has failed to comply with the terms and conditions of 
the registration as provided in certificate of registration;  
e. the marketing authorisation holder has failed to pay the prescribed retent ion fees within 
the prescribed time;  
f. the marketing authorisation holder has failed to submit periodic post -marketing 
surveillance reports;  
g. the marketing authorisa tion holder, intentionally and without justifiable reasons has failed 
to submit reports on adv erse effects; and  
h. Renewal of registration has been defaulted beyond the specified grace period.  
 
Article 2 4: Notice of suspension  
 
Any suspension shall be effected upon a written notice thereof. The notice for suspension of 
registered medicinal product sh all: 
 
a. set out the reason for the proposed suspension, any corrective action required to be taken 
and the time within which it must be taken;  
 
b. Require the marketing authorisation holder to show reasons as to why the suspension 
should not be effected.  
 
Article 2 5: Suspension or cancellation of registration without notice  
 
The Authority may cancel or suspend the registration of a medicinal product without prior notice 
if it is necessary to do so in order to prevent injury to the health or safety of patients, users or 
other persons.   Regulations Governing Registration of Medicinal Products  
 
 
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 The marketing authorization holder may apply to the Authority, in writing, requesting that the 
cancelation or suspension be uplifted.  
 
The Authority may, within thirty (30) days after the date of receiving the application review its  
decision.  
Article 2 6: Restoration of a cancelled or suspended registered medicinal product  
 
Pursuant to the provision of Articles 23, 24 and 25, the Authority may, upon satisfaction that the 
reasons of the suspension or cancellation of registered medicin al product has been corrected or if 
such reason for suspension or cancelation was unfounded, reinstate the registered medicinal 
product.  
 
Article 2 7: Refusal to grant marketing authorisation  
 
The Authority shall refuse to grant  marketing authorisation of a medicinal product if it is 
satisfied that:  
a. after verification of the particulars and evaluation of documents submitted in accordance 
with Article 6a, it appears that the applicant has not properly or sufficiently demonstrated 
the quality, safety or effic acy of the medicinal product;  
b. the methods used in, and the facilities and controls used for, the manufacture, processing, 
and packing of such medicine are inadequate to preserve its identity, strength, quality, 
and purity; or  
c. particulars or documents prov ided by the applicant in accordance with Article 6 a are 
incorrect or if the labelling and package inserts proposed by the applicant are not in 
accordance with relevant guidelines  
d. Any ingredient in the formulation if found to be listed as banned either in Rwanda or in 
any international convention for which Rwanda is signatory .  
 
Pursuant to the provision of the first paragraph of this Article , where the Authority may not  grant 
registration to a medicinal product, the Director General shall inform the applic ant in writing of 
such de cision and the reasons thereof  as stated below:  
 
a. The refusal of a marketing authorisation shall constitute a prohibition on the placing 
on the market of the medicinal product concer ned. 
 
b. The information about all refusals and the r easons for such refusal may be made 
publicly accessible on the authority’s website.  
  Regulations Governing Registration of Medicinal Products  
 
 
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 Article 2 8: Cancellation or revocation of marketing authorisation  
 
The Authority may cancel or revoke  the marketing authorization of a registered medicinal 
product if:  
a. it is not in the public interest that the registered medicinal product should be made or 
continue to be made available;  
b. the medicinal product has been banned in Rwanda;  
c. the medicinal product no longer meets the quality, safety and effectiveness 
requirements;  and  
d. the marketing authorisation has been suspended for a period of more than 12 months.  
  
A written notice of cancellation shall then be issued to the marketing authorisation holder, stating  
the reasons for cancellation.  
 
Article 29: Labelling and Packag e insert  
 
Every container of a medicinal product intended to be marketed in Rwanda shall be labelled in at 
least one of the official language used in Rwanda according to the relevant Guidance  on Format 
and Content of Labels.  
 
The package insert aimed at m edical  practitioners and other health professionals shall be drawn 
up in accordance with the summary of product characteristics as determined in the relevant 
Guidance on Format and Content o f Patient Information Leaflets.  
 
Article 3 0: Donation of medicinal  products  
 
Medicinal products to be donated shall comply to the relevant established Guidelines for 
donation of medical products.  
 
CHAPTER III: RESTRICTION FOR SALE OF UNREGISTERED MEDICINAL 
PRODUCT  
 
Article 31: Prohibitions  
 
No person shall manufacture,  prepare , store,  export,  sell, dispense, distribute or import medicinal 
products by either manufacturer, wholesale or retail unless it is in accordance with the provisions 
of these Regulations, and that person holds the appropriate registration certif icate i ssued by the 
Authority.   Regulations Governing Registration of Medicinal Products  
 
 
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 Article 32: Exemption  
 
Notwithstanding the provision of Article 31, these Regulations shall not apply to:  
 
a. any medicinal product prepared in a pharmacy and is done by or under the 
supervision of a pharmacist in accordance with a pr escription given by a licensed medical 
practitioner, dentist;  
 
b. any product prepared in a ho spital pharmacy in accordance with the formulas of a 
pharmacopoeia, and intended to be supplied directly to patients served by the concerned 
pharmacy and commonly re ferred to as the official formula;  
 
c. medicinal products intended to be used in research and development studies, without 
prejudice to the provisions of the Regulations on clinical trials in force;  
 
d. any medicinal products prepared and stocked in a hospital p harmacy by or under the 
supervision of a pharmacist with the view to dispensing as mentioned in paragraph (2); or  
 
e. any preparation made by a traditional health practitioner registered under Laws and 
Regulations currently enforced related to a traditional m edicine specifically prepared for 
administration or supply to a particular patient.  
 
f. Any medicinal product granted Authorization for Emergency Use by the authority 
following the declared public health emergency.  
 
g. Any person who prepares any preparation sha ll be duly bound and shall be held liable for 
any harm to the patient brought by the medicine.  
 
h. The authority may issue an expression of interests where the product is or are intended for 
treatment of rare diseases  
 
CHAPTER IV: MISCELLENIOUS AND FINAL PRO VISIONS  
Article 3 3: Advisory or Scientific C ommittee  
 
The Authority shall appoint an advisory or scientific committee, including external experts, to  
assist the Authority in making decisions, particularly in cases when greater knowledge is 
required or whe n a public health emergency occurs . 
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 Article 34: Appeals and review  
 
Any person aggrieved by a decision of the Authority may apply to the Authority for review of 
the decision showing grounds for dissatisfaction within thirty (30) days from the date of not ice. 
 
The Authority shall, within fifteen (15) days from the date of receiving the application, review, 
reject or vary its own decision.  
 
Notwithstanding the provision of first paragraph of this Article, the applicant shall not be barred 
from appealing to the Minister without applying to the Authority for review.   
If a person is dissatisfied with the decision after review, he may appeal to the chairperson of the 
Board of Directors of the Authority or the Minister whose decision shall be final.  
Article 35: Power to issue guidelines  
 
The Authority shall issue guidelines, SOPs, forms necessary for the implementation of these 
Regulations .  
Article 36: Admnistrative Sanctions  
 
A person who manufacture s, sells, distributes, import s or export s an unapproved medici nal 
product commits an administrative fault. He/She shall be liable for administrative fines 
equivalent to double the value of condem ned pr oducts plus tests related costs, when testing is 
compulsory . 
Article 37: Commencement and repealing  
 
This Regulation  shall enter into force on date of its signature and publication.  All prior contrary 
provisions to these regulations are hereby repealed.  
 
 
End of Document