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Nobles.com.jo

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.
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 Sterile products Aseptically prepared 1.1.1 Large volume parenterals 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 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) Non-sterile products 2.1 Solid dosage forms (tablets, hard shell capsules, dry suspension, powder, granules, 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) 2.10 Radiopharmaceuticals (per line) 2.11 other non-sterile products (specify) Biological medical products (per product- specify the product & the activity toward it) Primary packaging (specify dosage form) Secondary packaging 6.1 with quality control testing 6.1 without quality control testing 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).
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. 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

Source: http://www.nobles.com.jo/pdf/herbal_medicine%20/manufacturer/A-Manuf._site_reg._requirements.pdf