Form no.

1
1/1 (5pages)

Jordan FDA Registration Requirements for

Herbal Medicine/ Herbal Drug
Manufacturing Site
1-The foreign manufacturer should appoint Nobles Medical Supplies Co.
LTD – Nobles Drug Store P.O Box 840102 Amman Zip Code 11184
Jordan, as their agent representative through the attached agency
declaration form requested by Jordan FDA (duly legalized).
Duly legalized means that: this agency declaration should be legalized from
the manufacturer , chamber of commerce, notary public, ministry of justice,
foreign affairs ministry and Jordanian Embassy. In case there is no
Jordanian Embassy in your country then you can legalize from any Jordan
Embassy available in the near country to your country.

2- The manufacturer should prepared the site master file according to the
attached JFDA site master file content.. the site master file should be
sealed by the company seal and signed from the manufacturer (technical
director) on each page.

3- Good manufacturing practice certificate (GMP) must be valid ( at least

for 60% of its validity date) and issued by the health or the competent
authority in the county of origin and must declare clearly the following
points;
a) Name & address of the manufacturing site.
b) All the production lines.
c) The manufacturing site must follow the W.H.O manufacturing
practice of the pharmaceutical products.

Note;
3-1; In case that the country of origin don’t issue GMP certificate
( you must approve that by documents) then you can submit CPP certificate
from the country of origin for the product from the same production line
that you want to register in Jordan and the CPP certificate must indicate
that the manufacturer apply the good manufacturing practices according
to the who roles.
3-2; The GMP certificate must be duly legalized...duly legalized means
that: this certificate should be legalized from the health or the competent
authority, foreign affairs ministry and Jordan embassy.

4- Manufacturing license certificate must be valid and issued from the health
or the competent authority with number & new issued date and must
include all the productions lines that the manufacturer licensed to produce
plus the name & address of the manufacturing site (duly legalized).
Duly legalized means that: Same as item 3.

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5- Products list contain the following information; (product trade name,
generic name, pharmacological group, unite pack, dosage form, shelf life
and registration no & date in the country of origin. This should be sealed
and signed by the manufacturer on each page only.
6-The manufacturer production lines must be arranged according to this table;

No. Production Line List of products

produced on line
(INN/common name)-
attached
1 Sterile products
1.1 Aseptically prepared
1.1.1 Large volume parenterals
(conventional)
1.1.2 Small volume parenterals
(conventional)
1.1.2.1 Liquid vials
1.1.2.2 Liquid PFS (Pre-filled syringe)
1.1.2.3 Liquid amp
1.1.2.4 Power vials
1.1.2.5 Lyophilisates
1.1.2.6 Eye drops
1.1.3 Semi-solids (eye ointments/gels)
1.1.4 Large volume parenterals (blow-fill-
seal technology)
1.1.5 Small volume parenterals (blow-fill-
seal technology)
1.1.6 Eye drops (blow-fill-seal technology)
1.1.7 Solids & implants
1.1.8 Other a aseptically prepared products
(specify)
1.2 Terminally Sterilized
1.2.1 Large volume parenterals
1.2.2 Small volume parenterals
1.2.2.1 Liquid vials
1.2.2.2 Liquid PFS (Pre-filled syringe)
1.2.2.3 Liquid amp
1.2.2.4 Power vials
1.2.3 Semi-solids
1.2.4 Solids & implants
1.2.5 Other Terminally Sterilized prepared
products (specify)
2 Non-sterile products
2.1 Solid dosage forms (tablets, hard shell
capsules, dry suspension, powder, granules,

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 pellets)
2.2 Soft gelatin capsules
2.3 Chewing gums
2.4 Liquids for external use
2.5 Liquids for internal use
2.6 Medicinal gases
2.7 Aerosols (pressurized inhalations)
2.8 semi-solids
(creams/ointments/gels/sup./ovules)
2.9 Patches
2.10 Radiopharmaceuticals (per line)
2.11 other non-sterile products (specify)
3 Biological medical products (per product-
specify the product & the activity toward it)
4 Primary packaging (specify dosage form)
5 Secondary packaging
6 Batch release
6.1 with quality control testing
6.1 without quality control testing
7 Others (specify)
NOTE:
6-1;If the production line is for the products with special requirements e.g.
products containing penicillin, cephalosporin, other Beta- lactam
substances, or hormonal substances or potentially hazardous substances or
potent active products…This should be stated under the relevant
production line.
6-2; If some of the production lines specified above are on the same
production line in the manufacturing site this should be specified.
6-3; taking into consideration that the same machine may be produced the
(3) stated forms produced by the blow-fill-seal technology.

7- Factory machineries List, to be sealed by company seal and signed from the
manufacturer on each page only.
8-Colored Company layout (A3 paper size) for the manufacturing site and for
the personal, material flow….etc.

9-In order to avoid Jordan FDA inspection to your manufacturing site you
must provide one of the following documents:

ONE CPP certificate from USA FDA or EMA or Japan or Canada or

two (CPPS) from two of the following countries: (Germany, France,
Belgium, Switzerland, Holland, Sweden, UK, Austria, Fenland,
Australia and Spain).

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 NOTE:
9-1; The CPP certificate must be for product from the same production be
registered in Jordan…also the CPP certificate must be valid.
9-2; In case none of the above are not applying for you then you must
submit letter addressed to Jordan FDA that you agreed to Jordan
FDA to inspect your manufacturing site.

10-In case that you have manufacturing contract with other pharmaceutical
manufacturing sites for some or all of your products that you want to
register in Jordan, then you must prepare the documents requested in Items
no.(1 to 9) plus the following documents:

a) List of the products that will be manufactured according to the

manufacturing contract agreement
b) Original copy of the manufacturing contract agreement with clear
clarification for:
 A manufacturer company or (contract executor) agreed to
marketing authorization holder company (contract giver) the
possibility to inspect or check the production area, quality control
area, ware houses, manufacturing process, analysis process,
batches records and other technical matters.
 The responsibility of each part in the manufacturing contract
agreement about the manufacturing and quality control process.
 The name of the part responsible for the product batch releases.
 Duration of the agreement.

c) In case that you are manufacturing company according to the

manufacturing contract you must prepare two registration files:
I- One file for the manufacturer according to the documents
requested in items no.( 1 to 9)
II- The other file is for the marketing authorization holder company
according to the documents requested in items no. (1 to 10)...

IMPORTANT NOTES TO BE READ CAREFULLY;

1- Marketing authorization holder company (MHA) was defined by JFDA AS;
The company that responsible about the product quality, safety, efficacy &
to be guaranteed that the manufacturing process of the product are
according to the GMP roles that followed by WHO guidelines & must be
responsible about the finished product batch release for the market use,
follow up after the marketing (post marketing study)…etc. The MHA
company according to JFDA regulations must be only one of the
following;
I- THE MANUFACTURING SITE ITS SHELF.
II- OR COMMERCIAL OFFICE OWNED TO /OR BY THE
MANUFACTURING SITE.

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2- In case that the MHA company don’t involve in any role in the
manufacturing process of the product that will be registered in Jordan, then
it will be registered with JFDA without inspection…also in case the
manufacturing contract agreement if the contract giver is not involve in any
role in the manufacturing process of the product that will be registered in
Jordan then contract giver company will be registered with JFDA without
inspection.
3- In Jordan and according to JFDA regulations the contract manufacturing
agreement must between two working manufacturing sites …this mean that
the product contract giver company and the product contract executor
company must have their own working manufacturing sites.

4-All the signs from the manufacturer company and from MAH
Company should be from the technical director and to be sealed by
company seal on each page.
5-When there are no Jordan embassy you can legalize from any Jordan
embassy in the nearest country to your country.
6-The name and the address of the manufacturer and of the MAH must
be same in the following documents:
a) Site master file.
b) Agency declaration.
c) GMP certificate
d) Manufacturing license certificate.
e) Pricing certificate and CPP certificate.
7-The file must be organized very will with indexing and separators.

8-We want from you to send us two copies of the whole file contents
as follows:
a) Hard copy (paper copy).
b) Electronic copy (CD copy).

9-All the documents must be in English.

10-The SOPs or the documents requested to be attached with the site

master file must be in English.

Last updating 13/05/2014

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Agency Declaration

This agency declaration is made on / / by and between:

1. First party: we ............................................................................
A cooperation from ......................................................................
With executive office at..................................................................

2. Second party: Nobles Medical Supplies Co. Ltd. – Nobles Drug Store,
with executive office at Amman – Jordan, P.O box 840102, Zip code
11184.

Introduction:
Whereas the First Party is a famous company in the field of manufacturing
pharmaceutical products and has a desire to promote its products in Jordan
through Jordanian agent.

Whereas the Second Party is the sole and the exclusive distributor agent in
Jordan for pharmaceuticals companies.

Objective:
First party declare clearly that they are appointing the second party as their
exclusive sole agent and distributor in Jordan for their products specified in
the attached annex

Duration:
This agency declaration is valid for five years from: .......................................
..........................................................................................................................

Rights and Duties:

First party shall:

1. Honor any contracts for the sale of the products pursuant to this
agreement.
2. Comply with all the applicable laws and regulations relating to the
nature and methods of manufacture, handling, packing, labeling,
storage or shipping of the products.
3. Costs incurred in the relation of the registration required by the
relevant authorities in the territory shall be borne by the "first party ".
 4. First party shall be paid the registration-related costs upon invoice
drawn by "second party ". The invoice shall be supported by invoices
issued by the relevant authorities. Copies of original invoices shall be
translated into English.

Second Party:
1. Use reasonable efforts to negotiate and conclude transactions of the
sales of the products in Jordan. Shall issue a business plan specifying
the annual quantities that shall be sold from each product, after the
registration, as mentioned in the annex to the present agreement. Both
parties shall review these quantities at every six months, function to
the value of the realized sales and the forecasts for the following
period. In case that does not respect the previsions of this clause.

2. At all the times during the continuance of this agreement act towards
the first party dutifully and in good faith.

3. Warrants to first party that they will do his best in the marketing
efforts to market the products to the other customers to obtain
maximum sales value.

4. Immediately inform the first party of any observations and complaints

made by the customers in the respect of after sale defects in products
delivered and shall act in best interest. Will not accept or settle any
claim or damage unless approved and agreed by first party in writing.

5. Comply with all applicable laws and regulations relating to the sale of
the products (other than those relating to the nature, method of
manufacture, packaging or labeling of the products) and shall notify
the first party of any changes in the laws and regulations in Jordan
relating to the nature, method of manufacture, packaging or labeling
of the products which is received.

6. Shall be applier for all health and other registrations required for the
importation, sale and distribution of the products in the territory.

Earlier Treatment of This Agreement:

Either party may be terminated this agreement with justified reason without
punishment, informing the other party by written notice six (6) months in
advance without affecting the rights and the obligations of each party.
Settlement of Disputes and Arbitration:
Any dispute arising from or in connection with this agreement shall settle in
first instance friendly.
If a friendly settlement don’t reach within three months, the dispute or
differences shall be finally settled in accordance with the rules of
conciliation and arbitration of the International Chamber of Commerce or by
once or more arbitration designed according to the same rules. The
arbitration shall apply the principles of law generally recognized in
international trade as applicable to international contracts in Jordan
and/or….. (Mention your country name)

The first party signature The second party signature

Mr. Dr. Mohammed Abu- Naja

Title: Title: General Manager
Nobles medical supplies Co. - Nobles
Drug Store

Date of agreement:

P.S: Please note the following:

1- The agency declaration must be printed on the first party company

original formal paper.
2- The agency declaration must be legalized from Chamber of
commerce, notary public, foreign affairs Ministry and Jordan
Embassy in the country of the first party.
3- The first party must send to the second party the agency declaration
within (3-4 weeks) from the issuing date not later than.
4- Second party will sign the agency declaration after receiving it from
the first party you (duly legalized)…… so no need to send it to us
for sign before legalization in order to save time and money.
 Form no.1
(9 pages)

Jordan FDA Registration Requirements for Herbal

medicine / Drug Product.

1-Herbal medicine/herbal drug JFDA definition as; Every pharmaceutical

dosage form contain one medical plant/many medical plants or plant
extract/extractions and have medical claims/indications and may be
contains vitamins and or minerals.

2-Submit product classification request to the JFDA…the classification

request documents as;
I- Product composition certificate containing the active and inactive
substances and its concentration & activity function…this certificate
must be in English and to be printed in the manufacturer company
official paper then sign and sealed by the company seal and must
carry revision number & date.
II- 3 pcs of the product packaging material such as ( outer box, label ,
insert) in English ...incase that you don’t have English packaging
material then English color art work packaging material is accepted.
III- Finished product specification and analysis certificate in English.
IV- 5 pcs of the original product good in English packaging material …you
can apply item no; III.
Note;
The classification fee is 36 US and it takes (2-4 weeks.)

3- The manufacturer should fill the attached form (product registration

form).

This form should be sealed by company seal and signed from the
manufacturer only, by Technical Director on each page.

4-- The manufacturer should provide the CPP Certificate ( duly legalize)
according to WHO forms.

The CPP Certificate must contain the following:

- Trade name of the product

- Registration number & date at the health authority or the Competent
authority in the country of origin.
- Active ingredients & in active substances and its concentration.
- You must say clearly that the product is currently sold in your country, its not
enough to say that it’s authorized to sell.
- Name, address of marketing authorization holder and names, addresses of
all of manufacturing sites and its activities.

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5- The following documents should be submitted to Jordan FDA for each
product:

a- List of the countries names that the product was registered and used,
and to mention the registration number and date … if this is applicable.
b- List of countries names that the product is under registration…if this is
applicable.
c- List of the countries names that refused the registration of the product
and to mention the reason of the refusing … if this is applicable.
d- If items no. (a, b & c) are not applicable , kindly send a letter
addressed to the following address:
Jordan FDA
Drug Directorate
Registration Dept.
To clarify the situation... this letter to be printed in your company official
paper and to be signed by the authorized person and sealed by the
company seal … this letter doesn’t need any legalization.

6-List of substances from human origin or animal origin that interred in

the product formulation and the origin countries of these substance
with the requested related certificates for that…if it is not applicable
you must send a letter (from your company) certifying that the product
dose not contain any substance from human origin or animal origin.
And certificate to prove (BSE) free.
7-The manufacturer shall provide a pricing certificate informing about
the price in the country of origin (duly legalized) as follows:
 Trade name
 Generic name
 Dosage form
 Unite pack.
 Ex. Factory /Ex-work price in the country of origin in the local currency
and in USD when your local currency is not USD or Euro.
 Public price in the country of origin in the local currency and in USD when
your local currency is not USD or Euro.
 Pharmacy price in the country of origin in the local currency and in USD
when your local currency is not USD or Euro.
 C&F price to Jordan in the USD when your local currency is not USD or
Euro.

Notes:
Concerning the pricing certificate, kindly send us the additional following
documents:
a) A letter from your company (not legalized) saying that you will export to
Jordan the goods as C&F prices in USD when your local currency is not
USD.

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 b) In case that the pricing certificate is not legalized from your health
authority then we need a letter issued from your heath authority saying
that (it has no stated that in (mention your country name) neither the
health authority nor its local competent authorities do issue and legalize
pricing certificate, official price approvals for pharmaceutical products are
not required by law and the prices will be defined by the pharmaceutical
industry at its sole discretion)… duly legalized.

c) Pricing certificate from the manufacturer to explain Ex. Factory price, the
C&F price, the pharmacy price and the public price for this product in the
following countries (United Kingdom, France, Spain, Belgium Greece,
Holland, Australia, Cyprus Hangria, Ireland, News land, Portugal, Czech,
Carotia, Austria and Saudi Arabia) if it is applicable … if not, kindly send
us a letter to clarify this matter this certificate dose not need any
legalization.
d) In case that your health authority only issuing a pricing certificate contain
(Ex. Factory price, pharmacy price and public price only), we want from
you to provide us with pricing certificate from your company in their
official paper (only signed and sealed by the company) for your
suggested export price as C&F in USD to Jordan.
8-Declaration letter from the manufacturer company to declare the
following information:
a) The name of the manufacturing company and the address of the
manufacturing site
b) The name and the address of the marketing authorization holder.
c) The name and the address of the company that will issue the invoice.
d) The Export Center (The name of the city and the name of the Airport or the
Seaport.

9-Leaflet in English (in case that the mother language of the country of
origin is English) and this leaflet must be legalized from the competent
authority, and in case that the mother language of the origin country is
not English you will submit the following:
a) The translation copy (English copy) must be legalized from notary public
and then from chamber of commerce, foreign affairs ministry and Jordan
Embassy.

b) The origin country language leaflet copy must be original copy (not
photocopy) and must be legalized from your health or Competent Authority,
Chamber of Commerce, Foreign Affairs and Jordan Embassy.

c) In case that your product is generic product Jordan FDA requires original
copy of the Leaflet in English for the originator if it is available in your
country or for the market leader product in case that the originator is not
available in your country.

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NOTES;
Your Generic product leaflet that you want to register in Jordan must be
same as the originator product leaflet for the following information:
(Indication, contraindication, warning, precaution, side effects or adverse
effects, dosage and administration.)

10-Good agricultural and collection practices certificate (GACP) duly

legalized.
11-Mention each medical plant inter in the product composition with the
scientific name as (Genus, species, variety and author) the plant part in
Latin (English name & part used of the plant).
12-Analysis certificate to declare that the product is free from the
microbial organism that may will be harmful.
13-Analysis certificate to declare that the product is free from heavy
minerals such as (Lead, Mercury, Arsenic, Cadmium…etc) and free
from insecticide material & irradiation materials and particles.
14-Product Technical part must be as hard copy and sof copy and must
contain the following information:
a) Formula certificate ( must carry revision number & date) and method of
manufacturing
b) Active ingredient specification and method of analysis
c) Inactive ingredient specification and method of analysis
d) Specification of the primary and secondary package and one sample of
each (in English language).
e) Finished products method of analysis.
f) Validation of method of analysis.
g) Stability indicating method, degradation profile and the related component
chromatograms
h) Certificate of analysis for the raw material of the active and inactive
ingredient as follows:
1- One certificate from the raw material manufacturer
2- One certificate from the finished product manufacturer

i) Certificate of analysis for the finished product (for the same batch submitted
for registration with Jordan FDA )
j) Finished product specification at batch release and shelf life and must carry
revision date & number.
k) Stability studies :

I- Accelerated stability studies for the finished product at its marketing

package at 40ºC ± 2 ºC and 75% ± 5% Humidity or alternative storage
condition suitable for the nature of the product for duration of six months for
three batches as:
Two pilot batch (10% of production batch) and one batch lab scale …
manufactured at the same manufacturing site plant, these stability studies
will decide the shelf life also you must provide results statistical analysis for
the stability.

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 NOTE.: Six months stability for shelf life as 24 months or more.

II- Real stability studies at (30ºC ± 2 ºC and RH 65%± 5%) as storage

conditions for the whole shelf life.

P.S.:
1- In case that you don’t have complete real stability for the whole
shelf life, in this case you can submit the results that you have (at
least for one year) plus declaration letter to declare that you will
submit the complete results upon it finish.
2- Jordan according to the ICH Guidelines is consider as climate
zone III, this mean that the storage condition for Jordan will be as
store below 30ºC.

III – Description of the used stability batches (Batch size, Batch type, Batch
No, Manufacturing date, Exp date, package type and the storage
conditions).

IV- Batch analysis for all the Batches used in the A/M stability studies…
Evaluation of the result of the a/m stability studies…Scientific justification if
it’s required.

V- Conclusion of the stability studies and to confirm the shelf life, the storage
condition and the primary packaging material used for the product during
the stability study.

VI- Analytical method validation such as:

- Linearity
- Precision
- Accuracy
- Suitability
- Specificity
NOTE; you must attach the chromatograms of the analysis method
for active substance and degraded substances for the whole shelf
life.

VII- Clear and addressed chromatograms for the stability study for both (Real
and accelerated stability).
Kindly note the following about the chromatograms:
1. Clearly labeled chromatograms during the period of the stability study
should be presented.
2. Chromatograms that indicate the blank, the standard and the standards
of related substances (if applicable) must be presented which should be
clearly labeled.
3. Internal standards used in HPLC analysis should be stated and the
relative retention times (retention time of the compound / retention time of
the internal standard) should be reported.
4. All the peaks on the chromatograms should be labeled clearly (including
the solvent peak) or listed in clearly in a form of a table.
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 NOTE; 1.For accelerated stability the chromatograms interval must be
for zero time and six months time, in case the product has 24
months or more.
2. For real stability the chromatograms interval must be for zero
time, 12 months time, 18 months time & 24 months time in case
the product has 24 months as shelf life, and for zero time, 12
months time, 18 months time, 24 months time & 36 months …,
in case the product has 36 months or more as shelf life.

VIII- On going stability. .

NOTE; Technical part must be in the manufacturer formal paper
and to be sealed by company seal and signed on each page
from the technical director and must be in English.

15-Clinical studies as follows:

a) Clinical studies and Published scientific studies in international medical
journal.
b) Periodic safety updated report (PSUR).

Periodic safety updated report (PSUR); this PSUR is must to be

submitted with the registration documents for each product.
Putting in your consideration that according to ICH guidelines the PSUR
must contain the following information:

1. The product trade name, generic name, all of it's strengths and dosage forms,
plus the following information's:
a. The period time that the report covered.
b. The place and the date of product born.
c. The name and the address of the manufacturing site plus the name of the
agent in Jordan.
d. The date of the submitting the report to Jordan FDA.
e. The signature of the qualified pharmacovigilance person (QPP).

2. Product introduction, which include product summary (Name, Composition,

dosage form, indication, therapeutic efforts....)

3. World wide marketing authorization status for the product.

4. Update actions that has been taken against the Health authorities or the
manufacturer company since the product was registered as first time world
wide or in Jordan.
5. Comparison of the new safety information with the reference safety information
with the committed to use the originator leaflet information for the generic
product leaflet.

6. Patient Exposure for:

a. Clinical studies.
b. Market exposure.

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7. Individual case safety report (General consideration).

8. Post marketing studied that declare the safety which can be taken from
scientific reference or the internet.

9. Any other related efficiency date.

10. over all safety evaluation for the product which contains:
a. Line listing.
b. Abuse.
c. Side effect's regarding children and pregnancies.

11. Internal action plan to face any emergency action regarding the life
threatening products.

12. Appendix such as:

- CCDS
- CCSI
- SMPC
- Leaflet
- etc.

13. Scientific references.

16-Inside and outside packaging material requested information such

as:

A- Outer box carton:

- Product trade name and concentration
- Product active substances and their concentrations.
- Product inactive substances and their concentrations.
- Dosages form and package size.
- Route of Administrations.
- Batch number.
- Manuf. Date.
- Expiration date (month & year).
- Storage conditions (as store below 30ºC)
- Manufacturing name and address ( country and city or region)
- Marketing authorization holder name and address (country and city or
region) if applicable.

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 B- Bottle label: the same information of outer carton box.
C- Blister form:
- Product trade name and concentration.
- Product active substance and concentration in case that the product
contains one or two active substances.
- Expire date (month & year).
- Batch number.
- Marketing authorization holder name and/or manufacturer name.
D- Leaflet attached with the product (if applicable):
- Product trade name and concentration
- Product active substances and their concentrations.
- Product inactive substances and their concentrations.
- Indications
- Precaution
- Warnings
- Contraindication.
- Special instruction for the used of the product for children, pregnant,
lactation, old patients….etc.
- Over dose and how to deal with.
- Route of administration (dose & duration).
- Side effects.
- Dosage form.
- Unite package size
- Marketing Authorization Holder and/or manufacturer name plus the
address (country, city or region).
- The last revision date.
17- SMPC certificate and must be legalized.

18-(10) original labels in English

19-(10) original outer boxes (empty) in English

20- (10) Blister and Aluminum sheet (empty) in case of tab and cap form

21- (10) inner leaflet (original copies) in English

22-Raw Material supplier documents (Raw material master file):

a. Declaration letter from your company to determine the name and the
address of the raw material manufacturing site (Maximum three
manufacturing sites) that supply you with the raw material that you used
for your manufacturing process of your finished products. And you must
be committed to consider these manufacturing sites of the raw material
as your accredited or confirmed suppliers for the raw material that you
used.

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 b. Valid certificate of suitability (COS) for each active raw material (from
each manufacturing site) issued by:
European Directorate for quality of medicines certification unite
(EDQM) or copy of (COS)... in case the (COS) is not available so
you can submit GMP( notarized copy) or GMO copy legalized from
the Health or competent Authority in the country of origin of the raw
materials manufacturer and must be valid and must be for each
raw material manufacturing site.

c. Raw material specification and copy of reference specification in case

that it is (USP or BP).

d. Raw material analysis certificate from the raw material manufacturing site
and from the finished product-manufacturing site.

Last updating: 15/05/2014

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 Jordan FDA Drug Quality control lab documents and raw
materialsrequested for analysis process for product registration
purposes
1- First of all each product must be analyzed by JFDA QC lab before the
registration and the product must pass the analysis process in order to be
registered and priced.
2- JFDA Drug quality control lab asked for each product for the following
documents:
a- Finished product analysis certificate from the manufacture site of the
product for the same batch size of the samples that you will send for
the registration purposes.
b- Product composition or formula certificate.
c- Finished product specification at:
- The Batch release.
- The Shelf life.
d- Finished product method of analysis and must be in details and you
must mention all the calculation procedures needs for dissolution,
assay, related substance…etc.
e- Method of validation.
f- Leaflet/ Insert- in English…one copy.
g- Packaging material such as outer package, label, Blister….in English
and must be original copy.
h- Chromatograms at initial / zero time for:
- Assay.
- System suitability.
- Related samples / impurities.
- Dissolution.
- Preservation.
- Standards.
i- Working standard analysis certificate from the API manufacture and
from the finished product manufacture for the same batch.
j- Reference standard analysis certificate from the API manufacture and
from the finished product manufacture for the same batch plus the
safety data sheet.
k- Related substances / impuritiesplus safety data sheet.
3- JFDA drug quality control lab asked for each product for the following
Raw material samples:
a- Working standard.
b- Reference standard.
c- Related substances / impurities…if its applicable.
d- Preservative…. If its applicable
 Ps; You must mention in the bottle label for each material the
following information; substance name, batch no, manf.date,
exp.date ,qun. and storage condition.

4- JFDA drug quality control lab asked for each product for the following
finished goods samples as:

No. Dosage Form Unite Pack Samples Quantity

1- Tablets, Cap& Sachet 1-2 15 boxes.

3-5 15 boxes.
6-11 10 boxes.
12-49 5 boxes
50-100 5 boxes
2- Oral liquid vial & amp Same as tab, cap, Same as above
sachet& supp.
3- Syrups 1 bottle 15 boxes

PS:1- You must prepare the A/M documents for each product separately
and to be send in separated file or box with the product registration
documents and must be as hard copy and soft copy.

2- Concerning the samples quantity…kindly note that JFDA QC LAB

asked for these mentioned quantity for the registration analysis
purposes for each product.
 Registration Drug Department / JFDA

(Check List Regarding Documents Submitted For Drug Registration Purposes)

Applicant Name
Application Type: (check one)

Herbal Drug (HD)

Herbal Medicine (HM)

New ◊ Generic ◊

Drug Name & Conc.:

Pack Size and Type:

Drug Marketing Authorization Holder (M ِ AH) & Country:

Registration File content:-

YES / Page No
Part 1 Administrative Documents: NO

1-1 Check List ( Signed & Stamped)

1-2 Herbal Medicine Committee Form (5 copies)
1-3 Drug Package Leaflet (5 copies)
1-4 List of Similar Product Available in Local Market
1-5 JFDA approval letter of the Manufacturing site/s or copy of
request letter for approval ( date and number)
1-6 Herbal medicine Registration form
1-7 List from manufacturer declare the worldwide registration status
(registered \ Marketed ,under registration, rejected) .
1-8 Declaration from the manufacturer about the ingredient from
human or animal origin entering in the composition of the product
and their source and the related certificates(TSE ).
1-9 JFDA Stability Report
Part 2 Certificates

2-1 Certificate of Pharmaceutical product (CPP) according to WHO

format Certified and Legalized include:
*Product description (Name , Dosage form,Conc.)
*Active ingredient/s & Conc.
*Inactive ingredient/s & Conc.
*Freely Sold Statement.
*Registration Number & Date.
*MAH & Manufacturer/s Name & Address
* GMP statement
2-2 Prices: (for Exported products):
2-2-1 Public Price Certificate showing Price Structure: Ex.f, WSP, PP,
( Certified and Legalized):if vat included specify.
2-2-2 Public Prices including price structure from median countries
(UK, Spain, France, Greece, Italy, Belgium, and Holland).
2-2-3 Export Price Certificate
2-2-4 Export price from Saudi Arabia (if marketed)

3 ‫ من‬1 ‫صفحة‬
 2-3 Prices (for local products):
2-3-1 Suggested pharmacist price or hospital price .
2-3-2 Suggested Public price.
2-4 Certificate to prove freedom of BSE
2-5 SmPC Certified and Legalized from country of origin :
2-6 Leaflet Comparison between Generic & Originator (for generic drugs )
Part 3 Technical file :

Drug Product:
Drug formula.
Manufacturing Process.
Specifications of Excipients (inactive ingredients) & tests. *
Finished Product Specifications & Tests.(shelf life & Release) *Stamped &
Signed from manufacture.
Container Closure System: description of packaging material (primary &
secondary).
Methods of Analysis*.
Validation of Analytical method (for assay of API & degradation products
in the finished drug product ) with raw data and chromatograms.
Certificate of Analysis of Finished Product Stamped & Signed.
1- Stability Data Stamped & signed:
A. Full Composition
B .Batch Analysis
C .Stability protocol
C .Real Stability Data with raw data and chromatograms
D .Accelerated Stability with raw data and chromatograms
E .Photostability (if needed).
F .Use stability according to dosage form(reconstitution, inverted position ,
in use , etc).
G .Discussion of results
H .Conclusion (Shelf life & Storage condition)

2- Stability Commitments to Submit :

Complete Real Stability Data on pilot batches (if not completed at time of
submission).
Real Stability Data on production batches (if not submitted with file).
Ongoing stability (Real data as annual report).
*if pharmacopoeial a copy of the monograph should be included in the file.
* for excipients of animal ,human, microbial origin a TSE CEP should be included in the
file.
Part 4 Other requirement:
* For New Drugs:
Recent Published literatures (3 copies).
Clinical assessment report (3copies).
Periodic Safety Update Report (PSUR).

* For Herbal Drugs:

Certificate of GASP(Good Agricultural and Collection Practices)

Certificate of analysis for the pharmaceutical form declaring

3 ‫ من‬2 ‫صفحة‬
 its free of heavy metals such as: Lead, Mercury, Cadmium &
arsenic. As well as it’s free of insecticides, Isotopes &
impurities.
Certificate of analysis for the pharmaceutical form to be
registered indicating it's free of pathologic microscopic
microbes.
* THE FOLLOWING SHOULD BE INCLUDED WITH THE FILE:
-Package leaflet/insert.
-One Registration sample.
-CD (Electronic copy of technical file)

 ● FEES

- (Fees 1000 JD for Originator+100JD Stability(attached the receipt))

- (Fees100 JD for Generic drugs+ 100 JD Stability (attached the receipt))

 I declare that all the documents which refer to in this chick list are attached & number of
files Submitted for this application………………………………

…
-Name & Sign of responsible Pharmacist ----------------------------------------

-Name & Sign of JFDA Pharmacist ---------------------------------------

Date ----------------------

3 ‫ من‬3 ‫صفحة‬
 ‫نــــــــــموذج ( أ )‬
‫استمارة طلب تسجيل ‪ /‬إجازة دواء نباتي‬
‫)‪Form (A‬‬
‫‪Information Form for Herbal Medicine OR Drug‬‬

‫‪ -2‬عنوانه ‪.................................‬‬ ‫‪ -1‬اسم طالب التسجيل ‪ /‬اإلجازة ‪..............................‬‬

‫‪-2‬االسم التجاري والعممي لمشكل الصيدالني ‪:‬‬

‫‪..............................................................................................................‬‬

‫‪ -2‬الشكل الصيدالني( أقراص‪ ،‬كبسوالت‪ ،‬سائل ‪ ..‬الخ )‬

‫‪.............................................................................................................‬‬

‫الشركــة الصانعــــة‬

‫اسم الشركة الصانعة‬ ‫‪- 1‬‬

‫‪..............................................................................................................‬‬

‫‪- 2‬اسم الشركة مالكة حق التسويق‬

‫‪..............................................................................................................‬‬

‫عنوان مركزها الرئيسي‬ ‫‪- 3‬‬

‫‪..............................................................................................................‬‬

‫عنوان الفرع المصدر لألردن‬ ‫‪- 4‬‬

‫‪..............................................................................................................‬‬

‫اإلجراءات المتخذة من قبل الدائرة‬

‫تاريخ ورود الطمب‪...........................‬‬

‫رقم قيد الطمب بسجالت المجنة‪.............................‬‬

‫اسم الصيدالني المستمم وتوقيع ـ ـ ــه‪.‬‬ ‫الخاتم الرسمي‬

‫‪PAGE NO. (1) TO BE FILLED BY NOBLES DRUG STORE‬‬

‫‪1‬‬
1- Herbal Medicine/Drug Product
1/1 Name
............................................................................................................

............................................................................................................

1/2 Unit pack

...........................................................................................................

2- Manufacturer
2/1 Name
..........................................................................................................

2/2 Address
............................................................................................................

...........................................................................................................

2/3 Marketing Authorization Holder

............................................................................................................

2/4 Address
............................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

2/5 Address of the branch supplying Jordan

............................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

2
3- Composition

3/1 Active constituents and quantities/conc

............................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

3/2 Latin Names of Herbal Constituents / Quantities and Sources.

............................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

.......................................................................................................

3/3 Excepients
............................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

4- Packaging Materials
4/1 Type
............................................................................................................

3
............................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

..........................................................................................................

............................................................................................................

5- Shelf life
............................................................................................................

............................................................................................................

6- Label and Inserts

6/1Claims
............................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

6/2 Directions for Usage

............................................................................................................

............................................................................................................

............................................................................................................

6/3 Warnings / contra - indications

............................................................................................................

............................................................................................................

4
............................................................................................................

............................................................................................................

7- Recommended Dose
............................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

8- Other information
..........................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

............................................................................................................

5
 ‫التمهيدي‬
‫ة‬ ‫اإلجراءات‬

‫رقم كتاب تحويل عينات الدواء لممختبر‪ .................................‬تاريخه ‪/ /‬‬

‫‪/ /‬‬ ‫رقم نتيجة التحميل ‪ ............................... ... ....................‬تاريخه‬

‫‪......................................................................................................................‬‬

‫‪.........................................................................................................‬‬

‫‪.................................................................................................................‬‬

‫قرار المجنة‬

‫‪............................................................................................................‬‬

‫‪...........................................................................................................‬‬

‫‪...........................................................................................................‬‬

‫‪...........................................................................................................‬‬

‫الرئيس‬ ‫نائب الرئيس‬ ‫عضو‬ ‫عضو عضو‬

‫عضو‬ ‫عضو عضو‬

‫________________________________________________________‬

‫قرار المجنة في حال االعتراض‬

‫‪............................................................................................................‬‬

‫‪...........................................................................................................‬‬

‫‪...........................................................................................................‬‬

‫عضو نائب الرئيس الرئيس‬ ‫عضو عضو‬

‫عضو‬ ‫عضو عضو‬

‫‪PAGE NO. (6) TO BE FILLED BY JFDA‬‬

‫‪6‬‬