istration Requirements in Sudan :

dress and type of the foreign company.

address of local licensed local agent.

gency agreement certified by the Registrar of Companies

facturing license (photocopy) for the company to manufacture pharmaceutical products for use in the country
alth authority in the same country.

ement of Licensing Status of Pharmaceutical Product (SLSPP) conforming to the format recommended by the
ion, issued by competent certifying authority in the of origin authenticated, certified and stamped by Sudan Em
origin.

P certificate issued by competent certifying authority country of origin authenticated, certified and stamped b
n country of origin.

er divisions, subsidiaries etc. of the Mother Company their full address.

ntries where the company is registered confirmed photocopies of the certificates of registration in those count

mation and details about the pharmaceutical including at least the following information:

address of the drug manufacturing plant(s).

tablishment.

address of both Chairman of Board of Directors and Managing Director of the company.
US $ of local sales of products manufactured in the during previous 12 months.

US S of exported products manufactured in the plan names of importing countries during previous 12 months.

other than pharmaceuticals manufactured in that factory.

an of the factory, indicating location and floor area buildings and facilities.

technical full-time staff of the factory, their posts and qualifications (Name : Post': Qualifications ).

es and types of production.

jor equipment.

of any internationally recognized awards or certificates.

e or compliance with international standards, e.g. ICO 9001.

in research studies performed by the company during the last 5 to 10 years.

utical products released to the market based on the research.

useful information about the company, its manufacturing plants and their products.

cial forms, if any, are required.

Master file is required.

edelin Abd Elrahman

, Committee for Registration of
utical Products for Human Use.
ght 2002-2003 Embassy of the Republic of Sudn, New Delhi, India. Contact us. Designed and Developed by IA

PUBLIC OF THE SUDAN, MINISTRY OF HEALTH

ARD OF PHARMACY, KHARTOUM, SUDAN

L REQUIREMENTS FOR THE REGISTRATION OF

ACEUTICAL PRODUCTS

Requirements for the Registration of Pharmaceutical Products

ion
g to the Pharmacy and Poisons Act it is an offence to manufacture, import, sell, offer for sale any pharmaceuti
istered under the provisions of the Act, and regulations directives issued under the Act. So all applicants for
on of pharmaceutical products should be familiar with all such provisions and requirements issued by the Fed
Pharmacy. Directorate General of Pharmacy in the Federal Ministry of Health, the executive arm of the Boar

eutical products submitted for registration should be manufactured in a registered plant. The criteria for
on of a pharmaceutical product are:

lth or market need)

e over similar registered products.

Rules to Applicants for Registration of Pharmaceutical Products:

cant can receive application form for registration of pharmaceutical product from the DGOP.

ons for registration should -be submitted to the DGO according to the time schedule specified by the Directora

cant should be:

a valid wholesales pharmaceutical license and an agreement with the manufacturer.

ector establishment authorized by the Pharmacy and Act to deal with The applicant should fill two copies of th
d applicant in typewriter and should not overlook any information require part of the form. The prescribed du
ould be fixed first copy of the form. The applicant should also pay the prescribed application and registration
h the receipt to the application form.

certifying the accuracy of documentation and information submitted for registration should also be filled by
g signed by responsible person specified by the applicant.

cant should present with the application form, these documentation and samples (as shown in registration
nts). All documents should be in English and/or Arabic.

synopsis should be submitted with the application it should cover all aspects of the documentation with refere
cuments in a reference list. The general synopsis should provide a concise review of the information required b
harmaceutical product to enable it to consider the for registration. The general synopsis should be an accurat
on in the manufacture full data file. Claimed about registered products should be shown.

on for registration is accepted only for products produced in registered manufacturing plants.

mplete or incorrect documents will not be accepted.

ments not properly arranged and filed will not be accepted.

l requirements for locally manufactured pharmaceutical products:

mporary pre-registration approval is required for local manufactured products, which enables the manufactu
n of new pharmaceutical product for final registration applicant should submit the following documentation.

d prescribed application forms in three copies and overlook any information required in any part of the form.
d duty stamps should be fixed to the first copy of the form.

on formula showing amount and specification for ingredient and purpose for its use.

method of manufacture.

method of analysis.

ions of the finished product

or certificate of analysis.

or stability studies are required.

ype and material of packaging including pack sizes description of the inner and outer package.

he product pack insert.

ration Requirements:
ration file submitted should include the following documents.

ate of a Pharmaceutical Product (CPP)

on for registration

WHO type Certificate of a Pharmaceutical Product issued under WHO Certification Scheme on the Quality o
 utical Products moving in International Commerce.

icate of the Pharmaceutical Product should be issued by competent authority in the exporting country as notif
ated and stamped by Sudan Embassy in country of

troduction into the market in country of origin

osition formula in the Certificate of the Pharmaceutical Product should show A the active and inactive ingred

osition formula should be the same in country of origin

on licensing or authorization in other countries

list of the countries in which this product has been license for marketing. State for each.

ctions on sale or distribution

/closure system.

y of the certificate of registration in each of these countries.

ion formula
omplete composition and quantitative formula of that with justification and purpose of use of each ingredient w
g to reference book, which shows allowance for used ingredient for that purpose. This should show unit dose
mula.

ility of active and inactive ingredients and their effective product physicochemical properties should be shown

s of the Active Pharmaceutical Ingredients

t least the following information:
 redient(s) by international non-proprietary names generic or chemical name and their source(s).

data on the active ingredient(s) chemical structure solubility of active ingredient in water and other solvents s
anol, acetone and buffers of different, pH, and other physicochemical properties

formula (constitutional and empirical), molecular\of infrared, ultraviolet spectra.

redient present in the form of salts or hydrate should be described quantitatively by their total mass and by th
iety of the molecules.

on on the chemical stability of the active pharmaceutical ingredient and physicochemical stability of relevant.

address of manufacturer of Active Pharmaceutical Ingredient(s) (API) including any alternative manufacture
ite attach a GMP certificate issued by the drug control authority.

ions for the Active Pharmaceutical Ingredient

list of tests and limits for results for the active pharmaceutical active ingredient(s), including test methods in
details.,

he results of the methods of the assay of the (API) impurities.

edient is tested on the basis of a monograph in pharmacopoeia, it is sufficient to provide a copy of the monogr
with any test methods referenced but not duplicate monograph.

etails of any specifications additional to those in the pharmacopoeia.

ions for inactive ingredients

uality control specifications, certificate of analysis of materials.

list of tests and limits for results for each experiment (solvent, liquid to adjust pH, coating materials, capsule
 on the dosage from) including test method.

edient is tested on the basis of a monograph in a pharmacopoeia, it is sufficient to provide a copy of the mono
with any test methods referenced not in the monograph.

etails of any specifications additional to those in the pharmacopoeia, including microbiological limits for mat

uring procedure for the finished product:

detailed method of manufacturing procedure for the product, including packaging and showing all materials
uring process even if they do not appear in the final

s control procedures during manufacturing of the pharmaceutical product. Description of the finished product

ailed visual description of the finished product and packaging. Specifications of the finished product:

rmaceutical product applied for registration is including pharmacopoeia, its specification should be the same
dition of that Pharmacopoeia.

list of tests and limits for results for the finished pharmaceutical product details of test methods. If the ingredi
he basis of a monograph in a pharmacopoeia, provide copy of the monograph in that pharmacopoeia, togethe
eferenced but not duplicated in the monograph.

etails of any specifications additional to those in the pharmacopoeia. Provide both release and expiry limits fo

analysis of the finished product:

detailed method of analysis of the finished product determine its compliance with quality specifications
tion of active ingredient(s) of the finished product, purity, uniformity in performance, etc.). Difference betwee
ethod latest pharmacopoeial method should be justified.

he results of validation of the assay method for product formulation. For pharmacopoeial method provide data
ate that the method is applicable to this formulation.

rs/closure system(s) and other packaging:

ailed description of the container/closure system(s) including any liner or wading.

etails of the composition of each component.

other (e.g. outer) packaging, and state what materials are made from.

he specifications for any part of the container/closure system(s), which comes into contact with the product, or
, cover.

tal products, packaging components that will at and come into contact with any part of the product must comp
nts specified by the BP, USP, or EuP.

nformation and data about the stability of the container packaging materials to the product storage conditions

icate of analysis of the finished product:

riginal certificate of analysis of the same batch sub registration with batch number, manufacturing and expiry
ped by the quality control laboratory of the factory headed paper.

ibe package size

ata (according to WHO protocol)

he results of stability testing of the formulation in the proposed marketing pack. Results should include physica
tests.
uld also be provided on the product's stability during a processing prior to use that may recommended on the l
nformation, such as reconstitution of a powder, dilute injection, or dispersion of a tablet.

proposed shelf life with justification in terms of the stability testing, and the difference between release and
ons.

age conditions for the finished product.

data and information about degradation products submitted.

ect to both locally manufactured or imported product additional stability studies are required whenever major
ons are made to formulation, manufacturing process, packaging of preparation.

s used for accelerated and ongoing stability studies follows:

tability . Storage Temperature C Relative humidity % Duration studies (mon

ed ongoing stability studies (Plus-minus) 2 (plus-minus) 5 Minimum
ct package insert
ackage insert must be written in clear and understate terms for both prescriber and patient.
package insert should be at least written in an English or Arabic language(s).
y copies of the product pack insert should also be with the application forms.
ficate authenticated, certified by competent authority confirming that all information in the insert should be th
that country.

al information about the pharmaceutical product package insert:

ld include at least the following:
e of the pharmaceutical product, generic and scientific name.
rent dosage forms and strength available for this pharmaceutical product.
ber of doses of the medicinal product in case of more than one pharmaceutical dosage form or strength.
e of administration.
therapeutic group.
ations and dosage regimen.
raindications, warning, precautions and drug interactions
n pregnancy and other special group of patients.
erse effects.
rdose, signs, symptoms and treatment.

e and lablel:
eling of the outer pack should include at least following information:
e name of the pharmaceutical product.
ame of the active ingredient(s) showing the amount of present in a dosage unit.
ecification of active ingredient(s)
ckage size for retail sale (number of dosage units, weight and description of unit).
gistration number of the pharmaceutical products (if registered)
armaceutical dosage form.
orage conditions and precautions.
anufacturing and expiry date and batch number (should be in an uncoded form).
arnings or precautions that may be necessary.
Others (measuring unit,.)
he name, country and address of the manufacturer
egal status for distribution purposes (e.g. to be distributor on prescription onlv)
Package insert
Method of administration and the route of administration not for oral use.
Name of excipients to be of a safety concern for some patients or known to have a recognized action or effect.
ling of the inner (primary) pack should include at least the following information:
he trade name of the pharmaceutical product and form.
ame of active ingredient(s) showing the amount of present in a dosage unit.
ecification of the active ingredient(s).
anufacturing and expiry date and batch number.
e name and country of the manufacturer.
ute of administration, (if not for oral use).
Package size for retail sale, (number of dosage units, volume or weight per pack) except for tablets, capsules
r injection and suppositories (rectal and vaginal)

he following information.
posed C&F price for registration in Sudan. The specification of entry should be indicated.
lesale and retail price in country of origin (certified authenticated and stamped from the competent authority

le sale price in other countries including neighbouring countries to Sudan and African countries.
posed retail price for registration in Sudan.

nding Category
ate dispending category (proposed method for distribution in the country of origin with justification of that
ation (Over the Counter), pharmacy only, hospital only or prescribed.

rawal of product from markets

vide a list of all countries whore the product has been withdrawn from the market or where the application for
rejected or withdrawn by the applicant, state the reason case.

cy report:
pharmaceutical specialists submit detailed report of efficacy studies carried out on the product.
generic product submit detailed documentations of equivalence studies on the product in accordance to WHO
ndations, stamped and authenticated from the competent certifying authority in country of origin. This is requi
ached list.

ed advantage:
med advantage over the registered products should be shown and supported by reference to randomize, contr
ve trials. Details of these trials should be given in an appendix.

es of actual product and/or Reference Stand Substance:

Registration Department will request only one sample of actual products with document for approval. The rem
ence Standard will be requested after approval.
number of samples required for each dosage form on Table (1) and should be accompanied by the certificate
uantity of Reference Standard Substance, which is for testing at least TEN samples, should be submitted in an a
t resisting container and clearly labeled with the name, concentration, manufacturing date, and expiry date, b
torage conditions. An extra quantity should be supplied, if required.
ples of any other ingredient, that can be expected importance in the quality control of the specialty, should als
in sufficient amount for retesting at least TEN samples.

pecial requirements must be imposed on the storage of samples of Reference Standard are needed, their storag
should be written on the label of the inner and outer container.

al requirements for specific dosage forms

nce, colour, shape, friability, hardness, uniformity, with its specification, uniformity or thickness and diameter
on, moisture and dissolution in full details.

es:
nce, moisture,' colour, shape, brittleness, dissolutic description of appearance and the colour of the filled mat
y of weight with its specifications.

ons:
nce, colour, odour, pH, viscosity. It is recommended that a heating - cooling cycle to be employed between 4-4

ns:
nce, colour, odour, clarity of solution, pH

sions and powder for suspension

nce, precipitate and sedimentation rate, colour, odour, cloudiness particle size, disperability, redispersibility,
d particle size, colouring matters, flavour used and pH.
through the recommended storage period before reconstitution for powder of suspension.

and Elexirs:
on of colour, odour, taste and appearance, etc. pH specifications, refractive index with its specification, speci
with specification, colouring matters, flavour and preservatives used.

wder of external use:

nce, colour, odour, and moisture content.

lmic, Otical and Nasal preparations:

on, appearance, colour, clarity, viscosity, uniformity, volume, particle
ification and pH.
ative on lable (for ophthalmic preparations).

ble preparations
ontainer and sealing
nce, colour, clarity of solution, uniformity of weight, preservative (if applicable) and pH.
ion of solution on reconstitution of powder for injection, stability and strength through the recommended stor
reconstitution of powder for injection.

siteries:
nce, shape, colour, uniformity of weight, disintegration, or melting time with specification.

ent, Creams and Gels:

nce, colour, odour, consistency, viscosity, homogeneity, uniformity of weight, uniformity of content and water
tion.

ptic and Disinfectants:

nce, colour, clarity of solution and pH.
centration and recommended dilution for optimal
al spectrum
on of bactericidal, fungicidal and bacteriostatic action.

ol pharmaceutical:
ty of content (with limitation).
nt used
gredient/propellant ratio
sting
esting
measurement

onal requirements for pharmaceutical products containing new entities application

tities should be registered in countries that have a advanced system for registration of new drug entities. Prov
ntries and photocopy of registration certificate in these countries.
 on all pre-clinical and clinical studies should be sent to the Registration Department, including:

ological data:
ose toxicity, species used and route(s) of administration
dose toxicity, species, dose, duration, numbers a methods of evaluation
ction toxicity, dose, species and numbers of animal studies of teratogenic and embryotoxic effects.
cokinetic information to validate interspecies comparison toxicity

al Pharmacology:
action relevant to the proposed therapeutic use.
pharmacology on vital body systems.
ncentration effect relationship of primary or generation W pharmacological action
on, distribution, biotransformation and main routes elimination.

cal documentation Synopsis:

ical pharmacological studioes
cological action(s) of the drug in man.
urse of effect of single and multiple doses. Dose-response relationship and concentration effect relation
on, route of biotransformation, (if of pharmacology toxicological significance), routes of elimination.
bioavailability of products intended to have a system effect.

rapeutic efficacy:
ed trials carried out to support each claimed indication
nge use, modification of dosage in special group, e.g. children,
ly or malnourished individual, patients, with other irreversible effects.
ons with other drugs like to be given concurrently.
on with specific foods
e concerning dependency potential
drug been used in pregnancy? Is it excreted in bre Specific contraindications
endations concerning treatment of overdose or antidotes.

other relevant scientific informations

(1): Size of Samples to be Submitted for Registration

osage Form Number of sample (Unit) for QC lab Number of

(Unit) for
Committee

blets, capsules, 1 00 tablets, capsules or lozenges in 15 packs

enges, for original packs
pensing in
ginal pack to
ividual patient
rse of treatment
blets, capsules, 1 00 tablets, capsules or lozenges + 3 150 tablets
enges large pack empty packages capsules or
0 tablets, capsules lozenges + empty
more) pack

rups, oral 10 bottles 15 bottles

pension,
ulsions, elixir,
osols
y powder or 20 sachets 15 sachets
nules in sachets

ectable ampoules 50 ampoules + 3 empty packages 1 5 ampoules

d individual dose empty packages
l

ultidose vials 50 vials + 3 empty packages 15 vials + empty

package

ntments, creams, 10 tubes 15 tubes

drops (topical or
hthalmic)
ppositories or 100 suppositories or vaginal tablets 1 50
inal tablets suppositories or
vaginal tablets

EMENT FOR REGISTRATION AND RE-REGISTRATION FOR MINOR

ES REGARDING COMPANIES AND DRUGS

GE OF THE PACK/PACK SIZE AND/OR ADITIONAL PACK

t for minor change
bed form should be filled correctly by typewriting.
mples from each old and new pack
opy of Certificate of Registration in Sudan
ed price for the new pack (retail & wholesale)

GE IN THE INNER PACK

t for minor change
bed form should be filled correctly by typewriting.
mples from each old and new pack
opy of Certificate of Registration in Sudan
y study for the pharmaceutical product in the new pack
al from health authorities in the country of origin for pack
Certificate of Analysis
ed price for the new pack

NSION OR CHANGE OF SHELF LIFE OR STORAGE | CONDITIONS

t for changing shelf life or storage conditions
bed application form should be filled correctly
mples from each, old and new names, labeled i 4. Batch certificate of analysis

GE OF COMPANY NAME
ng letter with explanations
al of health authorities in the country of origin for company name authenticated
ped by Sudan Embassy, country of origin
ertificate of Pharmaceutical product for the new company name issued by the
horities in country of origin (as notified to WHO), certified by Ministry of
ffairs, authenticated stamped by Sudan
n country of origin.
mples from each, labeled with the new and old company name
ertificate of analysis.

GE OF PRICE OF PHARMACEUTICAL PRODUCT

t for changing price
bed application form should be filled correctly
ation for change of price should be explained.
ale price in the country of origin and other countries required
opy of certificate of registration in Sudan

NGE OF LOCAL AGENT OF A FOREIGN MANUFACTURER

ency agreement with the new local agent
ation of the previous agency agreement

EWAL OF REGISTRTION OF PHARMACEUTICAL PRODUCT

ed application form should be filled correctly
nt of renewal fees
opy of Certificate of Registration in Sudan
opy of last Certificate of Renewal of Registration in
ertificate of Pharmaceutical Product issued by the authorities in country of
notified to WHO), certified Ministry of Foreign Affairs, authenticated and
y Sudan Embassy in country of origin.
sion of application thirty days prior to expiration date of Certificate of
on on From (B,)

re is no Sudan Embassy in country of origin, the Registration Department will

n alternative.

edelin Abd EIrahman

, Committee for Registration of
utical Products for Human Use

ght 2002-2003 Embassy of the Republic of Sudan, New Delhi, India

Us
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