MONITORING BUREAU OF THE CHEMICAL-PHARMACEUTICAL PROFESSION REQUIREMENTS TO CONSIDER IN THE FOREIGN
PHARMACEUTICAL PRODUCT INSCRIPTION.
1.IN THE DOCUMENT:
1.1REQUEST DIRECTED TO THE SUPERIOR COUNCIL OF PUBLIC HEALTH:
a.) generals of the applicants (proxy and chemical-pharmacist)
b.) name of the specialty and its pharmaceutical form
c.) complete quali-quantitative composition formula (if there are any
artificial colorings are to be declared themlves of the following way:
FD&C Blue #1, Color index #42090.
d.) therapeutic indications
e.) contraindications, via of administration, dosage
f.) name of the manufacturer, place and country of origin
g.) express declaration of the responsible chemical-pharmacist
guaranteeing the veracity for the data to that one talks about the literal ones: b.), c.), d.) and e.).
h.) the request must be appropriately signed and aled by both
(proxy and responsible chemical-pharmacist)
1.2 IN THE CERTIFICATE OF FREE SALE (FOREIGN
SPECIALTIES) YOU MUST PROVIDE:
a.) commercial name
b.) generic name
c.) pharmaceutical form
d.) concentration
e.) name of manufacturer
勇敢的意思f.) country of precedence
g.) number of registry in country of origin
h.) quali-quantitative composition formula
i.) if the product requires medical prescription for sale or not
j.) Good Manufacturing Practices – GMP
THE CERTIFICATE ON MENTION WILL BE EXTENDED IN OWN FORMS OF THE CORRESPONDING AUTHORITIES OF HEALTH, APPOSTILLÉ OR
APPROPRIATELY AUTHENTICATED IN COUNTRY OF ORIGIN AND BY CONSULAR AUTHORITIES OF EL SALVADOR.
1.3 CERTIFICATE OF GOOD MANUFACTURING PRACTICES OF
THE MANUFACTURING LABORATORY (GMP) when not included in the certificate of free sales).
The original certificate emitted by the competent authority of the country of
origin, apostillé, or an authenticated copy of this certificate will be required, and which must be under effect.
1.4 CERTIFICATE OF QUALITY CONTROL FOR FINISHED PRODUCT, wich must provide:
a.) name of the specialty and its pharmaceutical form
b.) number of lot, date of manufacture, expiration date
c.) name of manufacturer and its precedence
d.) active principles and declared content
e.) bibliography consulted
f.) it must contain the tried determination, the limits of any chemical
and/or microbiological tests, (official and non-official), for finished
products and the their results corresponding to the lot of the
samples of the product prented for registry.
g.) it must be printed in own forms of the company, or of a laboratory
销售巨人of analysis properly authorized, and in original copy.
厚道图片h.) it must be signed and aled by the quality-control chemical-
pharmacist analyst, and/or al of warranty approval of the
respective quality control laboratory.
In any ca, the following determinations will reported as a minimum: TABLETS AND PLAIN COATED TABLETS
•Description, specifying form, color, and especial characteristics
•Dissolution (if it is required by Pharmacopea)
•Friability
•Humidity
•Identification and contents of active principle
•Uniformity of contents (applying corresponding method according to concentration of declared active principle).
HARD AND SOFT GELATIN CAPSULES
•Description specifying capsule´s color and mixture, special characteristics.
•Dissolution (If requested by Pharmacopea)
•Humidity
•Identification and contents of active principle
•Uniformity of contents (applying corresponding method according to Concentration of declared active principle)
ORAL DUST FOR SUSPENSION
•Description specifying color, special fluidity and characteristics before and after its reconstitution
•Weight average of mixture
•Humidity
•Reconstitution feasibility
•PH (already reconstituted)
•Identification and contents of active principles
•Microbial limits
DUST FOR INJECTABLE
•Description, specifying color, fluidity, and special characteristics before and after reconstitution
•Weight average of mixture
•Humidity
•Reconstitution feasibility
•PH (already reconstituted)
•Identification and contents of active principle by unit of dosage
•Sterility and pyrogens
•Test of Elisa (for the ca of vaccines)
DUST FOR TOPIC APPLICATION
•Description, specifying color, fluidity, and special characteristics •Contents per flask
•Humidity
•Identification and contents of active principle per gram or per 100 grams •Microbial limits
SOLTIONS (ORAL AND TOPIC)
•Description, specifying color and special characteristics
•pH
•Microbial limits
•Identification and contents of active principle per unit of dosage •Determination of alcoholic content (for elixires).
SUSPENSIONS AND EMULSIONS (ORALES, TOPICAS) •Description, specifying color and special characteristics
•PH
•Microbial limits
•Identification and contents of active principle per unit of dosage
SOLUTIONS, DUST FOR RECOSTITUTION AND OPHTHALMIC SUSPENSIONS
•Description specifying color and special characteristics
•Humidity (dusts)
•PH
•Sterility
•Identification and contents of active principle per unit of dosage
OTIC AND NASAL SOLUTIONS AND SUSPENSIONS • Description specifying color and special characteristics
• PH
• Microbial limits
• Identification and contents of active principle per unit of dosage
CREAMS, OINTMENTS AND GELS
•Description specifying color and special characteristics
•PH
•Microbial limits
•Identification and contents of active principle per gram or per 100 grams SUPPOSITORIES AND OVULES
•Description specifying color and special characteristics
•Microbial limits
•Identification and contents of active principle per unit of dosage
AEROSOLS
•Description
•Microbial limits
•Identification and contents of active principle
•Dosage of unloading with dosing valve
SOLUTIONS FOR INJECTABLES
•Description
•PH
•Sterility
矢车菊蓝•Pyrogens
•Identification and contents of active principle
PATCHES
•Description
•Identification of contents of active principle
GRANULES
•Description
•Identification and contents of active principle
•Microbial limits
耳机分类
FOAMS
•Description
•PH
•Identification and contents of active principle
•Microbial limits
1.5 DESCRIPTION OF THE METHOD OF ANALYSIS USED FOR FINISHED
PRODUCT:
Refers to the description in Spanish of the method ud for the finished product (physical, chemical and/or microbiological tests), taking as reference the Pharmacopeias, and/or own laboratory methods; including calculus performed, obtained graphs, and consulted bibliography.
1.6 MONOGAPHY OF ACTIVE PRINCIPLE
PHYSICAL AND CHEMICAL PROPERTIES
a.)Synonyms
b.)Structural formula and molecular weigh
c.)Description
d.)Solubility
e.)Us and incompatibilities with other chemical compounds
f.)Consulted bibliography
1.7 CERTIFICATE OF QUALI-QUANTITATIVE FORMULA
a.) Must be aled and signed by the one in charge of production or
quality control
b.) declare artificial coloring ud, with specifications given by FDA
and its corresponding certificate extended by provider
渴望蓝天
c.) medicines that contain alcohol in their formulation must be
declared with their degree of alcohol and volume.
1.8 PHARMACOLOGICAL INFORMATION OF THE ACTIVE
PRINCIPLE ON FINISHED PRODUCT
a.)category (pharmaceutical classification)
b.)indications
c.)pharmacokinetics致贫原因
•mechanism of action
•absorption
•distribution
•metabolism
•excretion
d.)warnings
e.)side effects
f.)dosage
g.)overdo
1.9 PHARMCOLOGICAL LITERATURES OF FINESHED
公司价值观PRODUCTS
