AFGHANISTAN GUIDELINES

Introduction
In order to protect the health of the Afghan people, the National Food and Spice
Administration of Afghanistan ensures the quality, effectiveness and safety of the
medicinal products supplied and produced in the country. For this purpose, before the
entry of spices and healthy products in the country, the information provided about the
quality and safety of the imported spices is evaluated through a transparent system,
and later the foreign manufacturing factory and its related products are registered.
The registration system of foreign factories and their medicinal products was
established for the first time in 1393 according to the procedures of the World Health
Organization and international standards. Since the establishment of the registration
system, 560 foreign factories producing spices containing 2000 items have been
registered. In order to further develop the system of evaluating and registering spices,
this procedure has been developed to register foreign factories and their medicinal
products. .
This procedure obliges the applicant to register the factory or medicinal product to
provide information and figures about the foreign manufacturing plant and the final
medicinal product to the National Food and Spice Administration. In this way, the
process of evaluation and registration of foreign factories or pharmaceutical products
in Afghanistan should be facilitated and accelerated by providing the required
information.
Based on
The first article
This procedure is based on the ruling of paragraph (2) of the sixteenth article of the
Spices Law and the sixteenth article of the regulation on the production and supply of
spices and accessories.
Tabi published the official gazette number (916) in order to regulate matters related to
the registration of foreign factories producing spices and products
Medicine has been formulated.
Goals
The second article
The main goals of this procedure are as follows
1- To provide a clear and transparent procedure for registering foreign factories
producing spices and their medicinal products in Afghanistan to ensure the quality,
safety, and effectiveness of spices.
2 Helping and guiding applicants to prepare an application and during the process of
registering generic products in the National Food and Spice Administration of
Afghanistan.
Idioms
Soum material
The second article of the following terms in this bill has the following meanings:
1- Active Pharmaceutical Ingredients (APD) is a substance or a mixture of substances
that is used for the purpose of producing a pharmaceutical form, and when used for
this purpose, the active ingredient forms that pharmaceutical form. -2- Certificate of

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Analysis (CoA) is an authentic document that shows the results of the analysis of a
specific batch
It shows production.
Composition (Composition) Composition refers to the components of a medicinal
product
is.
- Formulation is the composition of a medicinal form, including the characteristics of
raw materials and operations necessary for its processing.
5- Excipients are inactive medicinal substances that are used in the production of the
final product.
Finished Pharmaceutical Product (PPP) is a product that has passed all the
production steps and is labeled in the final packaging. A finished pharmaceutical
product can contain one or more active ingredients.
be medicinal
- Good Manufacturing Practices (GMP) means appropriate methods and standard of
activity implementation
are related to the production steps, which as part of the process of the pharmaceutical
quality assurance system ensures pharmaceutical products
In accordance with the quality standards suitable for the intended use and considering
the limitations of the license to supply to the market, production and control
have became.
The International Non-Proprietary Name (INN) is the abbreviation of the scientific
name of a medicinal substance, which is also known as the generic name, and is
selected by the International Non-Proprietary Names Program of the World Health
Organization.
has been selected. Non-proprietary international names are recognized worldwide.
A label is a printed text that includes a part of a spice package that contains the name
of the amount to be used and the composition
screw number, date of production and expiration date of the contents, and also the
name and address of the manufacturer or importer of the product
The license of the product, the authorized retail price and other relevant information
such as storage conditions are included in it.
10- Stringent Regulatory Authority (SRA) to the regulatory offices of the member
countries of the conference
The International Conference on Harmonization (ICH) is said to have
Strict requirements are regulatory matters.
11 US FDA Approval: if a medicinal product in terms of effectiveness
The safety and quality is acceptable to the US Food and Drug Administration
A number of countries can also be confirmed. 12 Company profile is a document
prepared by a factory for its complete introduction.
13- Site Master File is a document prepared by the spice factory and contains
information in
The issue of production location and control of production processes is presented
here.
14- Patient Information Leaflet is a sheet inside the medicine product box that contains
information and gifts about the product for the patient.

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15. Substandard means a product that does not meet the quality requirements and is
possible for the user
be unhelpful and tongue-in-cheek....

16- Shelf life is the period of time expected to last a medicinal active substance with
the final medicinal product if it is properly stored according to the specifications that
have been established in studies of the stability of a number of batches.
17- Storage condition is a condition that preserves the quality of the product in relation
to immunity, effectiveness and acceptability throughout the protective life that may be
predicted in stability studies. to guarantee The conditions described should include
temperature, humidity, light and other conditions. 18-Stability is the capacity of raw
materials with the final product to remain stable and preserved with the characteristics
of identity, purity, strength and other major physico-chemical, microbiological and
organoleptic properties during the protective life.
19. Stability studies are long-term and intensive and inter-album studies that are
carried out on the beaches
Initial or committed in accordance with an established protocol of stability to determine
with approval the duration of retesting of an active pharmaceutical ingredient
It is done with the protective life of the final medicinal product. 20- Variation means
any type of change that is made by the manufacturer in the medicinal active ingredient
of the formula, the production method, the place of production, the specifications of
the final product, packaging, labeling and the contents of the information sheet of the
final medicinal product. 21- Registration is the evaluation and registration of the spice
in order to allow its sale in the market and includes the evaluation of the safety,
effectiveness and quality of medicinal products.
22- Re-registration is the evaluation and re-registration of previously registered
factories and spices in order to ensure the safety, effectiveness and quality of
medicinal products.
23 Evaluation Evaluation is an accurate and independent measurement of the
activities carried out with the current one to obtain the extent and size of the Nile
To achieve goals and also to support decisions.
The first principle
General registration
Registration requirements of foreign factories
The fourth article
(1) Foreign factories producing spices, who want to register their products in this office
and supply them in the Afghan pharmaceutical market, must first register their
factories according to the requirements of this procedure. (2) Requests, information
and necessary documents must be in English, Dari or Pashto. (3) Application for
registration of a foreign spice production factory must be in the prescribed form of the
National Administration of Spices and Herbs. (4) The form must be filled out by a
competent person and confirm the correctness of all the information provided to the
National Food and Spice Administration. The applicant should know that if he submits
false and inaccurate statements and information to the National Food and Spices
Administration, it will be considered a violation and will be dealt with according to the
laws of Afghanistan. (5) The National Food and Spice Administration can visit the

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foreign spice production factory during the registration and ensure the physical
address of the factory, the nature of the work, the quality of the production lines, the
standard of the factory and compliance with the principles of good manufacturing
practices (GMT).
to do
(6) All the information that is provided to the National Food and Spice Administration is
confidential and is protected and stored.
Requirements for registration of medicinal products
The fifth article
(1) All forms of medicinal products used in Afghanistan must be registered in the
National Food and Spice Administration. (2) For the registration of medicinal items, it
is necessary that the desired spice is a national authorized spice of Afghanistan and
its manufacturing plant is in the administration.
National food and spice registered.
(3) All requests, information and supporting documents must be in one of English, Dari
and Pashto languages.
(4) The application for product registration must be in the prescribed form of the
National Food and Spice Administration and one application for each product. It is
necessary separately.
(5) Any type of change in the name of the characteristics of the packaging, the uses,
the contents of the product label, the patient information sheet or any characteristics
related to the registered product should not be made without the prior approval of the
National Food and Spice Administration. (6) If any change is made in the registered
product without the prior approval of the National Food and Spice Administration, the
registration of that product will be canceled.
becomes
(7) A product that is packaged together with a diluent is not considered as a combined
package.
(8) All information provided to the National Food and Spice Administration is
confidential and is kept in a safe manner.
Requested presentation
The sixth article
second chapter
Registration of foreign factories and pharmaceutical products
(1) The application for product registration must be in the prescribed form of the
National Food and Spice Administration and after signing and sealing, it must be
attached to the prescribed form.
to be submitted to the National Food and Spice Administration. A request for medicinal
products can have the following types: 1. A new request is a request to register a
product for the first time in the Afghan market. 2. A request for changes in a registered
product. A registered product must.
Taken.
There should be at least six in accordance with the requirements mentioned in the
change guidelines. 3 Application for renewal of registration All applications for renewal
of product registration shall be made one (1) month prior to expiration
The current registration date should be arranged.

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(2) If the factory is already registered in the National Food and Spice Administration.
There is no need to re-register the Baneh factory and a request should be made
To be provided for products or renewing the registration of a foreign manufacturing
plant.
Requested review of the seventh article
(1) The administration of the department is obliged to review the applications
submitted for the registration of pharmaceutical factories and pharmaceutical products
within 15 working days from the point of view of their completion.
(2) The National Food and Spice Administration may ask the applicant for information
about Lumat and the additional professor of Sani Kokami by e-mail. The applicant
must provide the requested information and documents within sixty (60) calendar days
from the date of receiving the email. If after the expiration of sixty (10) calendar days,
no response is received from the applicant, the said request will not be processed for
evaluation. In this case, the National Department of Food and Spices will issue a letter
of non-acceptance of the professor along with the submitted documents to the
applicant. Upon request, the applicant can arrange and submit a new application
according to the 16th article of this procedure.
(3) An application is accepted when the required documents are completed. in this
case
Confirmation of receipt of the request will be provided to the requester.
(4) An incomplete application submitted in a wrong or illegible form will be rejected.
The National Food and Spice Administration is one document
Appraisal on request for registration
Article VIII
(1) The department is obliged to set the appraiser to evaluate applications based on
first in fist out. The factory is managed by the Department of Registration and
Wayfinding. and the possible additional professor from the requester for information
about the happy factory, the National Food and Spice Administration, the date of
receipt (2) evaluation of the factory registration request (3) during the evaluation of the
professor, within sixty (10) calendar days from the request, the information and
documents requested and help. In reading, if the applicant does not provide any
answer or (10) queries. make If the answer is not received after the expiry of sixty
calendar days, the submitted request will be rejected. Upon request, the applicant can
arrange and submit a new application according to the 16th article of this procedure.
Deciding to register
Article IX
(1) The final decision regarding the approval or rejection of the application for the
registration of a foreign factory or medicinal product will be made after presenting the
evaluation results to the Technical Committee for the Evaluation and Registration of
Spices.
(2) The National Food Administration is obligated to officially notify the applicant of the
decision made. (3) The manufacturing plant is obliged, if the production of the
medicinal product registered with the license to market the medicinal product in the
producing country is completed, the issue
inform the National Food and Spice Administration in writing.
Factory registration number

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Article 10 (1) A registration number is given to a factory when it completes the
registration requirements and is approved by the National Administration
He has acquired food and spices.
(2) The registration number is specifically issued to the same factory whose name and
identity are specified in the master register. And this number
It should not be used for other factories.
Product registration stamp
The eleventh article
(1) A registration number is given to a product when a product registration request has
been completed and approved by the National Food and Spice Administration in terms
of quality, safety and
t composition
(2) The registration number is specifically issued to the same product that: the
identification name is specified. This number should not be used for other products.
Certificate of factory registration
The twelfth article
Specifications and its manufacturer in the registration documents
Factory registration certificate is issued with the name and address of the factory
specified in the registrar, and it is confirmed that foreign factories producing spices are
registered in the National Food and Spice Administration. If foreign factories are
registered in the National Food and Spice Administration, there is no need to re-
register the factory for his new mother.
Certificate of product registration
Article 13
Certificate of product registration stating the name, identity, combination of details,
name and address of the manufacturer of the final medicinal product in the master
The registration is specified, the title of the manufacturing plant is not issued. The
validity period of Muhammad's product registration is 5 years
Rejection and suspension of the application
Article fourteen
be
Whenever there are deficiencies in the teacher's submission or the request does not
meet the requirements of the recipe, the National Food and Spice Administration can.
Rejected or suspended the factory registration request. appeal in
Article fifteen
Against the decisions of the National Food and Spice Administration
(1) Whenever the application for registration of a factory is rejected by the National
Food and Spice Administration. The petitioner of Mitwa can request an appeal by
using the form prescribed by the National Food and Spices Administration. All appeals
must be filed in writing with the 1st administration within fifteen (15) calendar days
after the date of notification of the administration's decision.
National food and
2
The nazi applicant is obliged to be given an opportunity for sixty (10) calendar days
after the date of appeal to provide information and supporting staff. If the required

6
information is not provided within the mentioned period, the appeal will not be
accepted
and spices.
became.
Re-apply for registration of foreign factory or rejected product
Article sixteen
(1) Re-application for factory registration which is rejected due to non-compliance with
procedural requirements. for one (1) year
It is not acceptable after you leave.
Restricted
(2) Re-application for registration of products that have been rejected due to problems
in safety and effectiveness is not acceptable for a period of two (2) years after the
rejection of an application. Unless the mentioned product is registered in one of the
countries with a strict regulatory system (Stringent Regulatory Authority), he can
submit a request for product registration before the mentioned deadline by presenting
proof of safety and clinical effectiveness. (3) For any reason, the application for
registration of a product is rejected twice by the National Food and Spice
Administration. It is not allowed to apply for the third time unless it is registered in one
of the countries with a strict educational regulation system (SRA). Can
Submit a request for product registration.
Cancellation and suspension of factory registration privilege
Article seventeen
(1) The license of the registered factory can be revoked and suspended in the
following cases
1 In case it is received that the teacher provided is not real and sufficient or there has
been fraud. 2. If it is determined that the manufacturer does not follow good
manufacturing practices (GMP) or for any other reason commits
Violations are repeated.
3. In the event that none of the registered products are imported within three (3)
consecutive years, the National Food and Spice Administration
You can cancel the factory registration license.
For any other reason that the National Food and Spice Administration
It justifies the registration of the factory.
d. As soon as the factory registration license is revoked and suspended, the factory
must immediately return the registration certificate to the National Food and Spice
Administration.
Cancellation and suspension of medicinal product registration privilege
Article 18
When heroes
(1)
The registered product license can be canceled or suspended in the following cases.
be deleted 1 If the spice is from the list of permitted spices in Afghanistan
2 If it is found that the professor provided is not real and complete or there is even
fraud.

7
3. If it is proven that the product has serious side effects and based on the
recommendations of the World Health Organization (WH) or the competent national
and international authorities, its use is prohibited. WHO)
If it is determined that the manufacturer does not follow good manufacturing practices
(GMP) or for any other reason
Violations are repeated.
In the event that the market license holder and the supplier upon receiving the report
of serious or serious side effects of the product
registered to fail to inform the National Food and Spice Administration.
If the product is not imported within two (2) consecutive years after the product
registration license is issued. In case, without prior approval of the National Food and
Spice Administration, changes in the composition of the packaging label and other
specifications
The product has been imported.
. In case of failure to re-register the product in time before it expires. Dan has been
given a deadline
and for any other reason justified by the National Food and Spice Administration
during the revocation of the product's registration license. 10. As soon as the product
registration license is revoked and suspended, the holder of the marketing license
must immediately submit a registration certificate. Product to the office
Meli returned food and spices.
Cancellation of registration
Article 19
The holder of the marketing license is obliged to notify the National Food and Spices
Administration in writing of the decision he makes regarding abandoning the product
registration before the expiration of the registration period, stating the reasons, and
immediately submit the product registration confirmation letter to the National
Administration.
He brought back food and spices.
Reassemble the product
Article 20
Owner . The license to supply the market and the supplier are obliged to re-collect
non-immune or defective products. In addition to responsibility
They have to inform the National Food and Spice Administration about the decision to
collect the product again
Before or with the knowledge of the National Food and Spice Administration.
Factory and product registration validity period
Article twenty one
(1) The period of registration of the plant and medicinal product is valid for five (5)
years, unless it is earlier than the mentioned period.
be suspended and canceled by the National Food and Spices Administration, or the
license holder will give up.
(2) The National Food and Spice Administration will provide the reason for suspension
or rejection of registration in writing. In the same way, the license holder must give the
reason for termination
Provide product registration.

8
(3) If the registration license of a factory and product is terminated before the
expiration date, the previous license will not be renewed. Building
A new application must be submitted for factory and product registration.
Renewal of factory and product registration license
Article 22 (1) To renew the factory and product registration license, the request must
be at least
6 months before the expiration date of the factory and product registration certificate to
be submitted to the National Food and Spice Administration.
(2) As soon as the validity period of factory and product registration expires, the
request for renewal of registration is not acceptable, if the license holder
Supplying the market with a request for renewing the registration of the factory and the
product did not present a new request for the registration of the factory and
The product should be presented.
Change in registered product specifications
Article twenty-three, the holder of the market license and the supplier is obliged to
inform the National Food and Spice Administration of any change in the registered
product.
to give All requests for changes to the registered product must be in accordance with
the "Changes" guideline. Change in the supplier of the registered product
Article twenty-four

The privilege of the registered product supply license may be transferred from the
current supplier to another supplier. All requests to transfer to another supplier must
be in accordance with the "Changes" guideline.
Awarz unwanted after
Article twenty five
The holder of the market license and the supplier is obliged to protect the National
Food and Spice Administration from any unwanted side effects caused by the use
Notify the registered product as soon as it receives the news.
Product complaint
Article twenty-six
The holder of the market license and the supplier in case of knowledge of any kind of
problem related to the product quality of the registered products)
Must inform the National Food and Spice Administration.
Laboratory test
The twenty-seventh article of the National Food and Spice Administration is obliged to
test the samples of the registered products for compliance with the standards of
pharmacopoeias.
get official
Chapter III
Foreign factory registration requirements
Foreign factory registration requirements
Article twenty-eight
(1) The applicant is obliged to submit the following documents and information to the
National Food and Spice Administration for factory registration.

9
1. The request letter, through which the request form and related documents are
submitted, must be on the main page of the request company's factory and must be
signed and dated by the responsible person, who can be the president or deputy (or
person
with the other competence of the requesting company's factory.
2 The application form completed and signed by a person must be filled in. A person is
obliged to confirm the accuracy of all the information he has provided to the National
Food and Spice Administration.
3. A letter of delegation of authority from a foreign spice production factory should be
submitted during the factory registration request, (if the applicant is a foreign spice
production factory, the aforementioned letter is not necessary, the letter of delegation
of authority must be stamped and signed by the president and or the vice president of
the factory through the official e-mail address
be shared by the manufacturing plant.
Present the latest spice production license issued by the spice regulatory agency of
the producing country. If there is more than one production location, provide a spice
production license for each of the production locations. (Permit(s) to produce spices
should
Confirmed by three competent bodies of the producing country, the Spices Regulatory
Department of the Ministry of Commerce and the Ministry of Foreign Affairs, and
through Etshe
The business of the Afghan embassy in that country should be approved and
presented. If there is no Afghan embassy in that country, the ambassador
A non-resident can approve the permit(s).
Factory profile that is up-to-date and complete.
Certificate of Good Manufacturing Practices (GMP) issued by an accredited body of
the regulatory authority of the country of origin or departments
The regulation of countries (SRA) has been issued. If there is more than one
production location for each of
The production sites must provide a certificate of Good Manufacturing Practices
(GMP). The certificate(s) must be certified by three competent bodies of the producing
country, the National Food and Spice Administration, Trade and Foreign Affairs, and
through the embassy's commercial office.
Afghanistan is confirmed in that country, if there is no Afghan embassy in that country,
the non-resident ambassador can
Confirm certification letter(s) Other additional information such as FDA certification
Provide the certificate of the countries with strict system and so on. Manufacturing
License, if available
Presenting the certification of the International Standard Organization (ISO) or
international organizations regarding quality management
to do
The products are available for sale in the producing country and other countries that e
has been
Each page 1
It is by your factory
productive

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Seal and Signature
10 list of manufactured products that each page is mentioned by the foreign factory
and
The regulatory office of the country that produces the seal and signature 11. The total
amount of transactions in the last three years, each year separately, with the
separation of foreign sales and
has been
The domestic provides 12 registration status of foreign factories producing spices in
the country of origin and other countries, which includes information about the status
to do
Registration of medicinal products in the country of origin and other countries and
providing the certificate of registration of the same product in the second country by
email
Official factory
13 The master file of the production location of the factory, if there is more than one
production location for each of the locations
Produce a copy of the master file according to the relevant guidelines.
14 quality assurance report of the applicant factory's pharmaceutical items, if they
were imported with a one-time permission before the factory's registration
be
15. If the result of quality control for 3 batches is negative, the company cannot be
registered.
16 Obtaining confirmation of the documents provided by the supply company from the
regulatory office of the producing country. 17 report of the assessment of the good
production practices of the producer company by the regulatory authority of the
producer country
Chapter 3 requirements for registration of medicinal product
Product registration requirements
Article twenty-ninth
(1) The request letter, which was on the original page of the applicant company's
factory, by the responsible person, mentioning the date and
The signature of the head or vice president of the requesting company's factory.
(2) Completed and signed application form for the registration of each item of the
final medicinal product, a completed home form with the date mentioned and
Signature should be provided
(3) The authorization letter was sealed and signed by the applicant from the
manufacturing plant during the application for product registration. The head or vice
president of the factory should be sent to the National Food and Spice Administration
through the official address of the factory.
Confirmation letters
Article 30
(1) The applicant must provide the following certificates for the product registration
application
1. A copy of the production license issued by the competent authority of the
producer country
2 A copy of the business license

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3. A copy of the product production permit issued by the competent authority of the
producer country)
4. A copy of the certificate of pharmaceutical product (Certificate of Pharmaceutical
Product (CoPP)) (issued by
Department with the authority of the producing country in the World Health
Organization format approved by the National Food and Spice Administration, Ministry
of Trade and Ministry
foreign affairs of that country
5 A copy of the site master file (Site Master File)
6 A copy of the certificate of Good Manufacturing Practices (GMP) "Manufacturing site
7 A copy of Certificate of Analysis (CoA)
8 A certified copy of the certificate of product registration in one of the other
countries. The certificate of registration of the second country is the source
The official email of the partner manufacturer or the link to register the product in the
second country) should be provided.
And according to the regulation of production and supply, the result of the quality
stabilization of the medicinal items that is registered is mandatory and after the
confirmation of the embassy
related to be imported to Afghanistan and quality confirmed by the laboratory.
Product labeling conditions
Article thirty-one
(1) The applicant must provide a sample or a draft of the proposed label of the
product he applied for registration according to the rules
and to provide the pharmaceutical regulations of Afghanistan.
(2) The label must be in English, Dari or Pashto.
Product information sheet
Article thirty-two
(1) The applicant must submit a sample or draft of a patient information sheet
about the product in order to register the product
requested to provide
(2) Information about the product must be in one of English, Dari and Pashto
languages.
Active medicinal ingredient
Article thirty-three
The applicant is obliged to provide information about the medicinal active ingredient in
the following order:
the name of the active ingredient, which includes the international non-proprietary
name, the proper name, the chemical name, the code number of the company or
manufacturing laboratory, and the registration number in the American Chemists
Association and Other names such as US accepted names
United States (USAN), approved name of England (BAN) and accepted name of
Japan)
(2) properties and characteristics of medicinal active substances according to
valid and accepted pharmacopoeias
(3) Details of the place/places of production of medicinal active substances

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(4) Synthesis methods of medicinal active ingredients according to valid and
accepted pharmacopoeias according to the guidelines for registration of spices.
(5) Confirmation of Analysis (COA) for at least two batches produced by each
synthesizer from each manufacturing site, including the results of impurities.
(6) Description of the systems) of the covered container, including each of the
components of the primary packaging and their specifications
(7) The results of the stability test of at least 3 batches of medicinal active
ingredients have been verified and sealed
The final product of the thirty-fourth article
FINISHED PRODUCT
The applicant is obliged to provide information about the final product in the following
order:
(1) The description of the final medicinal product should include the physical
characteristics of the available strength, the mechanism of distribution in the
membership
(2) The formulation that includes all the components of the medicinal form and their
amount based on the unit, task or activity of the components, with the reference of its
quality standards and if a substance performs several tasks, mention the most
important task.
(3) The results of the development of medicinal products according to the
guidelines for registration of foreign factories and medicinal products of the National
Food Administration
(4) results of dissolution in artificial environment or release of spice according to
registration guidelines
(5) Information about the production locations of the final medicinal product
according to the registration guidelines
(6) Detailed description and validation of the final medicinal product production
method according to the registration guidelines
(7) Description of the specifications of the materials according to the registration
guidelines
(8) control of the final medicinal product according to the registration guidelines
(9) Description of container system - cover and other packaging according to
registration guidelines
(10) The results of the drug stability tests of the final product are confirmed and
sealed
(11) The results of the analysis of at least three batches) are confirmed and sealed
Information efficiency
The thirty-fifth article in
The applicant is obliged to provide information about the safety and effectiveness of
the medicinal product as follows:
(1) New active pharmaceutical ingredients
(2) New indication
(3) New application methods
(4) New medicinal form
(5) All medicinal forms moderated in release
(6) New compounds in the active ingredient

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Factory visit requirements
Article thirty-six
Fourth Season
Factory visit
(1) In order to ensure the eligibility of foreign factories producing spices to register the
factory and its products before granting the certificate, the National Food and Spice
Administration Board is obliged to visit the factories as follows:
1. It is mandatory for new factories that have applied for registration. 2. It is required to
remove foreign factories from the black list.
For previously registered factories (Grand Fathered), the administration will decide as
necessary.
The administration will decide to renew the registration as necessary.
(2) The National Food and Spice Administration can, depending on the necessity,
before the evaluation process of the documents during the evaluation or at the end of
the evaluation
Document the visit.
(3) The factory visit is carried out at the expense of the foreign factory at the
suggestion of the relevant department and the approval of the department.
(4) In the following cases, the visit of the delegation to the factory is not mandatory
1 production lines that have a certificate from one of the World Health Organization's
registration regulatory offices;
2 factories whose requested products are approved by the United States Food and
Drug Administration (US FDA).
3 factories whose requested products are approved by the World Health Organization
(WHO Prequalified)? The purpose of the factory visit
Article thirty-seven
The purpose of visiting production lines of foreign factories is as follows
Ensuring the physical address and building standards of the factory
2 Evaluation of factory production permit conditions and related documents provided
in accordance with its activity
Ensuring compliance with Good Manufacturing Practices (GMP), Good Storage
Practices (GSP) and Good Laboratory Practices
(GLP) and other criteria
- 4- Making sure of
The specific delegation of competencies and responsibilities under a specific
formation of human resources
Ensuring the authenticity of the provided copies of certificates
Ensuring the effectiveness and efficiency of production processes used in the
production of medicinal products
Ensuring the existence of technical personnel in the production lines of the factory
- Ensuring the authenticity of the sources of raw materials and specific contracts
between the producer of the final product and the raw materials
There is.
- Ensuring the cleaning of machinery after each production and existence of Line
Clearance after the production of each batch 10- Ensuring the timely calibration of
laboratory devices in QC and IPQC laboratories

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11. Ensuring validation of production devices and equipment
12- Ensuring the efficiency of the ventilation system (HVAC) and the water supply
system of the production sectors 13- Ensuring the regulation of the warehouses of
active medicinal substances and finished products in accordance with the accepted
standards
14- Ensuring the documentation of the mandatory items of factory activities
15. Ensuring that SOPs are implemented
16- Ensuring the existence and implementation of quality management in all activities
of the factory, especially the production department
The fifth chapter
Registration fees
Office registration fee
Article thirty-eight
(1) The registration fee and the following fees will be collected from the applicant
1 The application fee for registration per item of medicinal product is 1000 (one
thousand Afghanis) per application, which can be applied after the application
payment is
The evaluation fee per item of medicinal product is five hundred dollars (500) which
can be paid before the evaluation.
2 The product registration fee is 1000 dollars per item, which can be paid before the
certificate is granted.
The product re-registration fee is 1000 dollars per item, which can be paid before the
certificate is granted. 4. The fee for changing the supplier of the registered product is
1,000 (one thousand dollars) after going through the process and obtaining the
certificate.
It is payable.
5. The fee for changing the registered specifications of the product is 200 (two
hundred dollars).
The fee for changing the name of the factory is 500 five hundred dollars
6. The fee for the loss of the product registration certificate is $100
Article thirty-nine
The sixth chapter
Blacklist and product removal
Being blacklisted
(1) According to the forty-ninth article of the import and production regulations,
whenever at least three items of the producing company (company) are not proven in
terms of quantitative and qualitative control in accordance with internationally
accepted standards, the importation of the said company is prohibited.
placed and included in the black list.
(2) For any other reason that the National Food and Spices Administration can justify
when placing in the black list
Article 40
Getting out of the blacklist
(1) Factories that are included in the black list according to Article 49 of the Production
and Supply Regulation after the expiration of the registration deadline.
Items can be removed from the blacklist as follows:

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1. The defect in the quality of the products produced by the foreign factory has been
identified and accompanied by documents
Confirmation of defect removal should be submitted to the National Food and Spice
Administration.
2 The National Food and Spice Administration is obliged to visit the foreign factory and
confirm the elimination of the defect. 3. After the approval of the department to fix the
defect of the foreign factory, the supply company can register again according to this
procedure
factory and its medicinal products.
(2) Factories of previously registered factories (grand father) whose items are not
registered after being included in the black list for up to 3 years cannot submit a
request to be removed from the black list.
Article forty-one
Deleted factories
(1) Factories whose registration deadline has been completed have not re-registered
despite the notification of the relevant department. Since then, the factories registered
in the National Food and Spice Administration have been removed, and until the re-
registration of the films and the submission of the necessary documents, the import
permit will not be allowed.
will not earn
Article forty-two
Re-registration of deleted factories
(1) Companies that have already supplied Amitaz from relevant foreign factories by
submitting a request to re-register it.
They can make factories and items.
(2) In case the previous franchise owner company has become inactive, other
companies can by submitting documents according to this procedure
Make a new registration.
(3) Factories that are active in the administration, but relevant supply companies do
not supply spices from them and want to request concessions.
are, if the previous supply company did not supply spices from this factory in the last 3
years and the factory agreed with
The company has ended and the deadline for registering its products has been
completed. For other companies, you can contact the mentioned factory by submitting
a letter
Delegation of authority and its confirmation through the official email of the
manufacturing plant and registered line contract and the need for the company's
agreement
It does not have a previous one.
(4)
The seventh chapter
Final rulings
Application of work methods
Article forty-four
The National Food and Spice Administration is responsible for implementing this
procedure for registering foreign factories and imported spices.

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Renewing work styles
The forty-fifth article of this procedure will be renewed according to the requirements
of the registration system.
Necessity
Article forty-six
This procedure, which is arranged in seven chapters and forty-six articles, will be
applicable after approval.
Registration Fees (Cost)
The registration fee and other fees are received from the applicant as follows:
1 - Application fee: 1,000 thousand Afghanis for registration of each pen per national
product is executed after the request (application). 2 - Evaluation fee: (500) per pen
per national product It is one hundred dollars that must be paid before the evaluation.
1000) is gold, which must be executed before issuing the certificate. 5- The change
(change) fee in the registered product is (1000) thousand dollars, after the completion
of the steps of the process and when receiving the certificate, it is enforceable. 2- In
the registered characteristics (specifications). The change fee (2006) is two hundred
dollars. The fee for changing the name of the registered factory (500) is five hundred
dollars.
- The fee for a new certificate (100) hundred dollars when the certificate of registration
of the product is lost.

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