Iinformation and Documents Required from Manufacturer of Pharmaceutical Product

1- The manufacturer should fill the attached registration form.
This form should be sealed by company seal and signed from
the manufacturer only, by Technical Director on each page.

2- The manufacturer should provide a Free Sales Certificate or CPP saying that the item is currently sold in the country of origin.

Free Sale Certificate or CPP must contains the following:

Notes:

  1. In case that the products is not sold in the country of origin then you must explain why, and to submit free sales certificate or CPP from one of the following countries (USA, UK, Canada, Germany, France, Belgium, Switzerland, Holland, Sweden, Australia, Japan, Austria, Fenland and Spain)
  2. You must use the WHO form
  3. The products must be registered and used in the country of origin at least for one year before registering it in Jordan.
  4. If your products was registered in one or two countries which werementioned in (item a) kindly provide us with the free sales certificate or CPP from these countries because this will help us in the registration process with Jordan FDA without inspecting the plant.
  5. The free sales certificate or CPP should be duly legalized

 

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

  1. List of the countries' names that this product was registered and used , and to mention the registration number and date ... if this is applicable.
  2. List of countries' names in which the product is under registration ... if this is applicable.
  3. List of the countries' names that refused the registration of the product and to mention the reason of the refusal ... if this is applicable.
  4. If items no. (a, b & c) are not applicable , kindly send a letter addressed to the following address:

Jordan FDA Drug Directorate Registration Dept.

And 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.
  P.S: Kindly note that in case that items no. (a, b & c) is applicable ... you must prepare a letter the same as we explain to you in item no. (d).

4- List of substances from human origin or animal origin that interred in the product formulation and the origin countries of these substances with the requested related certificates for that... if it is not applicable you must send a letter (from your company) certifying that the product does not contain any substance from human origin or animal origin.

5- The manufacturer shall provide a pricing certificate informing about the price in the country of origin (duly legalized) as follows:

Notes:
Concerning the pricing certificate, kindly send us the additional following documents:

  1. a letter from you (not legalized) saying that you will export to Jordan the goods as CIF prices in USD when your local currency is not USD or Euro.
  2. 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 not stated that in (mention your country name) neither the health authority nor its local competent authorities do issue or 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.
  3. Pricing certificate from the manufacturer to explain the Ex. Factory price, the CIF price, the pharmacy price and the public price for this product in the following countries (United Kingdom, France, Spain, Italy, Germany, Greece, Holland and Saudi Arabia) if it is applicable ... if not, kindly send us a letter to clarify this matter, that this certificate does not need any legalization.
6-Declaration letter from the manufacturing company to declare the following information:
  1. The name of the manufacturing company and the address of the manufacturing site
  2. The name and the address of the marketing authorization holder.
  3. The name and the address of the company that will issue the invoice.
  4. The Export Center (The name of the city and the name of the Airport or the Seaport).
7- Insert in English (in case that the mother language of the country of origin is English) and this insert must be legalized from the competent authority ... in case that the mother language of the origin country is not English you will submit the following:
  1. The translated copy (English copy) must be legalized from notary public and then from Chamber of Commerce, Foreign Affairs Ministry and Jordan Embassy.
  2. The original country language copy must be original (not photocopy) and must be legalized from your Competent Authority, Chamber of Commerce, Foreign Affairs Ministry and Jordan Embassy.
  3. IN case that your product s generic product, Jordan FDA requires an original copy of the insert 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.

Note: your generic product’s insert that you want to register in Jordan must be the same as the originator product’s insert for the following information: (indication, contraindication, warning, precaution, side or adverse effects, dosage and administration).

8- Product Technical part must be as hard copy and electronic copy and must contain the following information:
  1. Formula and method of manufacturing
  2. Active ingredient specification and method of analysis
  3. Inactive ingredient specification and method of analysis
  4. Specification of the primary and secondary package and one sample of each (in English language).
  5. Finished products method of analysis.
  6. Validation of method of analysis.
  7. Stability indicating method, degradation profile and the related component chromatograms
  8. 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
  9. Certificate of analysis for the finished product (the same batch submitted for registration with Jordan FDA )
  10. Finished product specification
  11. Stability studies :
    1. Accelerated stability studies for the finished product at its marketing package at 40 C and 75% 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.

    2. Real stability studies at the adopted storage conditions for 12 months as follows:
      1. The results of the first 6 months to be submitted upon the submission of the registration file
      2. The other 6 months results can be submitted later on or submission of real stability studies to cover all the shelf life period

      P.S. This is applicable for the new products but if you have complete real stability studies for the whole shelf life of the products it will be better.

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

      Note: Jordan according to the ICH Guidelines is considered as climate zone III, this means that the storage condition for Jordan will be as follows:

      1. Store below 30˚ C ± 2.
      2. RH 65% ± 5%.

    4. 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 its required.
    5. 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.
    6. Analytical method validation such as:
      • Linearity
      • Precision
      • Accuracy
      • Suitability
      • Specificity

      P.S. You must attach the chromatograms of the analysis method for active substance and degraded substances.

    7. Clear and addressed chromatograms for the stability study for both (Real and accelerated stability) to cover all the shelf life... 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.
      5. If extension for the expiry date is asked. Chromatograms should be provided that covers the extended time asked for the shelf life.
    8. Ongoing stability for the goods from the market (if it is available)

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.

9- Clinical studies as follows:
  1. Originated products:
    • Bioavailability study
    • Clinical studies
    • published scientific studies in international medical journal.
    • Periodic safety updates report (PSUR).
  2. Generic products ... we need Bioequivalency study when it is applicableapplicable and periodic safety updated report (PSUR). This (PSUR) must 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:
      1. The period time that the report covered.
      2. The place and the date of product born.
      3. The name and the address of the manufacturing site plus the name of the agent in Jordan.
      4. The date of submitting the report to Jordan FDA.
      5. The signature of the qualified pharmacovigilance person (QPP).
    2. Product introduction which includes product summary (name, compositon, dosage form, indication, therapeutic efforts…).
    3. World wide marketing authorization status for the product.
    4. Update actions that have 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 and the committed to use originator insert information for the generic product insert.
    6. Patient exposure for :
      1. Clinical studies.
      2. Market exposure.
    7. Individual case safety report (General consideration).
    8. Post marketing studies 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:
      1. line listing
      2. Abuse.
      3. Side effects regarding children and pregnancies.
    11. Internal action plan to face any emergency action regarding the life threatening products.
    12. Appendix such as:
      • CCDS
      • CCSI
      • Leaflet
      • Etc…
    13. Scientific references.

    The Bioequivalence study must contain the following:

    1. All the generic pharmaceutical products which have systemic action and not as liquid dosage form need Bioequivalence study.
    2. Name and signature of (IRB) committee member that agreed on the study form, putting in your consideration that the members of (IRB) must be at least five persons.
    3. Copy (in English) of the center (that did the study) dependence certificate issued from health or controlled authority in the country of origin which declared that the center follows GCP and GLP and this certificate must be valid during the preparing process of the study.
    4. 5-20% of the chromatograms must be addressed and declare the date and the time of taking the samples.
    5. In-vitro Dissolution study between the reference product and the product of the study.
    6. CD for the Bioequivalence study.
    7. Statistics power analysis declares that the number of the participations is enough.
    8. Hard copy (paper copy) for the Bioequivalence study.
10- Inside and out side packaging material requested information:
  1. Product trade name and concentration
  2. Product active substances and their concentrations.
  3. Product inactive substances and their concentrations.
  4. Dosages form and package size.
  5. Route of Administrations.
  6. Batch number.
  7. Expiration date.
  8. Storage conditions
  9. Manufacturing name and address ( country and city or region)
  10. Marketing authorization holder name and address (country and city or region) if applicable.

P.S: Kindly note that these a/m information must be mentioned in all the product packaging material such as (label, and outer pack) with the following exceptional:

  1. For blister form in case of tablet and capsules form you must mention the following information:
    • Trade name
    • Active substances and concentration in case that the product contains one or two active substances
    • Batch number.
    • Expiration date.
    • Manufacturing name and /or marketing authorization holder.
    authorization holder.
  2. Small pack and small label (2 ml pack and below )... you must mention the following information :
    • Trade name
    • Routes of administration
    • Expire date
    • Package size ... when it is applicable.
    • Manufacturer name or marketing authorization holder in case that there is no trade name for the product.
11- Products insert information: 12- The manufacturer should provide (10) original goods as samples which he intends to introduce into Jordanian market, taking into theconsideration the following:
  1. The outer boxes, labels and insert to be in English language
  2. The samples should be same as the goods which will be exported to Jordan market after the registration.

P.S. in case that your packaging material is not in English, you can use black and white English draft packaging material for registration purposes only.

13- Five (5) original labels in English

14- Five (5) original outer boxes ( empty) in English

15- Five (5) Blister and Aluminum sheets (empty) in case of tab and cap form ( packaging material used for tab and cap form)

16- Fifteen (15) inner inserts (original copies) in English

17-Raw materials: the manufacturer should supply samples of standard raw material used for each product (active and inactive) with analysis certificate for this raw material, and this analysis certificate must be from the raw material manufacturer and from the finished product manufacturer. Jordan FDA quality control lab asks for the following raw materials for analysis purposes in the registration process for any registration file:

  1. Working and reference standard material for the active ingredients and their analysis certification.
  2. Working and reference standard material for preservatives (if present n the formula) and their analysis certification.
  3. Related substances, impurities reference standard and their analysis certificate.

Important Notes:

  1. Once the above requirements are completed by the manufacture, we will submit the documents to Jordan FDA for registration and pricing, Pricing will depend on :
    1. The public price and Ex-factory price and pharmacy price of the item in the country of origin
    2. The exported prices to Saudi Arabia... if its applicable.
    3. The public price in European countries... if its applicable
    4. The public price in USA, Canada, Australia, Japan... if its applicable
  2. All the signs from the manufacturer should be done by the technical director.
  3. When there is no Jordan Embassy you can legalized from any other Arabic Embassy.
  4. All the registration requirements should be applied for each item and each dosage form.

    e.g. : If you have for one item three dosage forms for one item , so we need the
    registration requirements for each dosage form alone (one registration documents set for each form)

  5. From each product registration documents we want three copies (one original copy and two non- original copies, not original), each copy to be in one file and to be arranged well with separators and clear indexing.
  6. You are kindly requested to send us one draft copy of the registration documents before legalization in order to recheck (in order to save time and money) and we will return it back to you very soon.
  7. In case that the product is manufactured as (contract manufacturing) we want you to submit open part of the contract between the manufacturer and the manufacturing authorization holder, signed and sealed from the manufacturer and the marketing authorization holder and you must clarify the following points in the contract:
    1. Manufacturer agreed for the marketing authorization holder to check and control at any time the production area, control area, storage condition, manufacturing area, analysis area, the batch record and other technical facilities...
    2. Responsibility of the manufacturer and the marketing authorization holder about the manufacturing and controlling procedures.
    3. The name of personal responsible about product batches release.
    4. The contract validity period.
    5. If the product contains any plasma derivatives, you must submit plasma master file.
  8. Kindly note the following Authorized Authority for pricing, that are considered by Jordan FDA :

    No

    Country Name

    Pricing Authorized Authority

    Notes

    1

    UK

    The certificate Issued and authenticated from:
    National Health Service or Department of Health
      • BNF
      • Druggist & Chemist

    2

    France

    Ministry of Economy, Finance & Industry Jointly with the ministry of health, Family & Disabled
    (The certificates issued from The Manuf. Company and authenticated from:
    Les Enterprises du Medicament (LEEM)

    It is published in :
    Jounal Officel De La Republique Francaise

    3

    Germany

    Federal Ministry of Economics and Labour.
    10109 Berlin
    Department ICY
    Seharnhorstsrasse 34-37
    10115 Berlin, (www.bmwa.bund.de)

    It Is published in :
    IFS Or DIMDI (www.dimdi.de)

    4

    Greece

    General Secretariat of commerce Kaningos Square
    Athens 10181 (taking into consideration that the certificates Issued and authenticated from them)

     

    5

    Holland

    Dutch Ministry of Health, Welfare & Sport
    The certificate Issued from the manufacturer and authenticated from:
    The Chamber of Commerce for Industry & Trade

    www.farmatee.nl-prijsvorming/pdf/prijslijst.pdf

    6

    Spain

    Ministerio De Sanidad Y Consumo (taking into consideration that the certificates Issued and authenticated from them)

    It Is published in :
    Spanish National Formulary
    And: www.portalfarma.com.home.nsf

    7

    Italy

    Ministero Della Salute (Direzione Generale Farmacie dei dispositivi medici)
    The certificate Issued from the manufacturer and authenticated from:
    The Italian M.O.H

    The authorized prices appears on this site:
    www.sanita.it
    It Is published in:
    Linformatore Farmaceutico book.
    And It Is published from:
    Gazzetta Ufficiale Della Repubblica Italiana

    8

    Saudi Arabia

    The Certificate Issued And Authenticated From:
    M.O.H – General Office for medical & pharmaceutical Licenses

     

    9

    Sweden

    The pharmaceutical Benefits Board
    Lakemedelsformanamnden
    P.O. box 55,5-1711 Solna/Sweden

     

    10

    Switzerland

    Office Federal de Sante (OFS) Berne, Switzerland , (The certificates issued from The Manuf. Company and authenticated from Chamber of Commerce)

    The authorized prices appears on this site:
    www.bag.odmin.ch/kv/gesetze/sl/f/index.htm

    11

    Austria

    Federal Ministry Of Health And Women
    (Taking Into Consideration That The Certificates Issued From Them) And Authenticated from Chamber of Commerce

    It is published in:
    Austria Codex

    12

    India

    Ministry of Chemicals and Fertilizers / Government of India

    Only essential life saving drugs are published in the Gazette of India

    13

    Korea

    Pharmaceutical & Food Policy Division
    Ministry of Health & Walfare

     

    14

    Macedonia

    Ministry of Economy
    Issued and authenticated the authorized price list.

    It Is published from:
    Official Gazette of the Republic of Macedonia

    15

    Belgium

    Belgian Federal public Service Economy, SMES, Self-Employed and Energy Division Prices & Competition (taking into consideration that the certificates issued and authenticated from them)

    It Is published from:
    Repertoire Commente Des Medicaments

    16

    Denmark

    Danish medicines agency (Laegemiddelstyrelsen) taking into consideration that the certificates issued and authenticated from them

     

    17

    Portugal

    The director – General for Trade & Competetion (Taking Into Consideration That The Certificates Issued and Authenticated from Chamber of Commerce for Industry & Trade.)

     

    18

    China

    (Province) Drug Administration Bureau People's Republic of China + Notarial Certificate

     

    19

    Australia

    Australian Government
    Department of Health and Aging

    It Is published in:
    Schedule of Pharmaceutical Benefits

    20

    Turkey

    Ministry of health and Social Aid
    General Directorate of Pharmaceuticals and Pharmacy
    Issued and Authenticated the Drug Price Declaration

     

    21

    Romania

    Minister of Health and Family
    Pharmaceutical General Directorate

    www.msf-dgf.ro

    22

    Cyprus

    Issued From The Manufacturing Company and Authenticated from Ministry of Health in Cyprus

     

    23

    Tunisia

    Ministry of Industry
    General Office for Competition and Economic Research

     

    Notes:

    1. Arabic Countries from their M.O.H. for every country.
    2. The Prices Certificates are accepted by Jordan FDA in case that they are issued from the Ministry of Health in the Specific Country.
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