How to Implement Computer-Assisted Drug Registration - A Practical Guide for Drug Regulatory Authorities - Regulatory Support Series No. 002
(1998; 74 pages)
Índice de contenido
Ver el documentoACKNOWLEDGEMENTS
Abrir esta carpeta y ver su contenidoI. INTRODUCTION
Abrir esta carpeta y ver su contenidoII. PRE-REQUISITES FOR COMPUTER-ASSISTED DRUG REGISTRATION
Abrir esta carpeta y ver su contenidoIII. PREPARING FOR COMPUTER-ASSISTED DRUG REGISTRATION
Cerrar esta carpetaIV. COMPUTERIZING DRUG REGISTRATION
Ver el documentoA. Data to Be Computerized
Ver el documentoB. Preparing Data
Ver el documentoC. Options for Entering Data into the System
Ver el documentoD. Using the Computer in the Drug Registration Process
Ver el documentoE. Train Staff
Ver el documentoF. Ensure Computer System Support
Abrir esta carpeta y ver su contenidoV. MAINTAINING A COMPUTER-ASSISTED DRUG REGISTRATION SYSTEM
Abrir esta carpeta y ver su contenidoANNEXES
 

A. Data to Be Computerized

Data to be recorded may include any or all of the following elements; some of these data are applicable only to domestic companies.

Data Describing Companies and Institutions

Code

Activity (e.g., manufacturer,

Authorization to handle

Full name (e.g., Pharmachem

 

importer, retail pharmacy,

 

psychotropic and narcotic

 

Laboratories of Karibland,

 

QC laboratory, etc.)

 

drugs

 

Ltd.)

Status (e.g., currently active,

Reports of previous

Short name (e.g., Pharmachem)

 

cancelled, operational

 

inspections

Mailing address

 

licence expired, etc.)

Planned inspections

Plant address

Date of validity of status

Various types of

Phone and fax

Responsible pharmacist

 

authorization

E-mail

Property/functional relations

 

numbers

Contact person

 

with other companies

 

Data Describing the Item for which the Application Is Submitted

Application number

Limitations of distribution/use

Official product information

Date of reception

Origin

 

sheet (indications,

Applicant name

Human/veterinary

 

contraindications, etc.)

Representative of the applicant

Linkage code with social

Internal evaluation sheet

 

(or other company related in

 

security or other system

 

(information not to be

 

some way to the application)

Physical location of the

 

published, assessment

Drug product name/trademark

 

application files

 

reports)

Type of product

Shelf life and storage

Prices

 

(brand/generic)

 

conditions

Distributors/importers

Product generic name

Manufacturers involved in the

Veterinary information

Dosage strength

 

different phases of production

General description of the

Dosage form

 

and their roles and

 

appearance of the drug item

Primary container and its

 

responsible persons

Analytical information

 

specifications

Active and inactive ingredients

Regulatory status in other

Presentation(s)

 

and their quantities and

 

countries

Type of MA requested/issued

 

functions, using INNs when

 

Dispensing category

 

available

 

Narcotic/psychotropic

Therapeutic classification

 

Routes of administration

   

Data Describing Status

• Decisions made at the different steps of the assessment process, indicating dates at which each step starts/ends, and responsible person

• Date and type of final decision

• Date and cause of rejection of applications or cancellation of marketing authorization

• Date of issuance of marketing authorization and renewal of marketing authorization

• Date on which marketing started, was suspended, was resumed

• Post-marketing information on adverse drug reactions (ADR), stability, other, and date on which each of these was valid

Data Describing Variations

• Data before and after variation, date of variation, person who authorized the variation

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Última actualización: le 3 mayo 2013