Draft Guidelines For The Qualified Person (Pharmacist) In WholeSale Distribution Of Medicinals

Guideline 1A Authority and Responsibility of the Q.P.

The pharmacist appointed as Q.P. shall:
1. Have a clear reporting line to either the licence holder or the Managing Director.
2. Have access to all areas, sites, stores and records, which relate to the licensable activities being carried out.
3. Regularly review and monitor all such areas, sites, etc, or have delegated arrangements, whereby he/she receives written reports that such actions have been carried out on his/her behalf. Where arrangements are delegated, the Q.P. remains responsible and he/she shall personally carry out the delegated functions at least once a year.
4. Focus on the management of licensable activities, the accuracy and quality of records, compliance with established standard operating procedures, the quality of handling and storage equipment and facilities, and the standards achieved.
5. Keep appropriate records relating to the discharge of his/her responsibilities.
6. Make it clear that, although it is his/her own responsibility, everyone has a role to play in Good Wholesale and Distribution Practice.
7. Find ways of ensuring that the senior management of the licence holder recognizes and shares the responsibility for issues the integrity of which depends also on the senior management. e.g. Putting things in writing, Regular signed checks, Regular memos.

The Q.P. should also have a personal knowledge of:
1. The duties and responsibilities of Qualified Persons as laid down by the DH
2. The conditions of the Wholesale License for which he/she is nominated.
3. The products under the licence and the conditions necessary for their storage and distribution.
4. The categories of persons to whom products may be distributed.
5. Reference – Schedule 3 of the Regulations pertaining to Standard provisions for Wholesale dealer’s Licences in Chapter 5.1 of the “Orange Guide”.

Guideline 1B
Responsibility of the Licence Holder

“the licensee shall be responsible to provide the pharmacist with all the requirements to be able to fulfill his role and to abide with the conditions of the license (DH Circular No. 143/99, Point 2 – para. 2, last sentence.) The licensee should be legally bound to abide by this recommendation, thereby acknowledging the Q.P. the authority to exercise this role.
Kindly refer to attached example of such a form.
N.B. According to Article 19 of Ch. IV, EU Directive 75/319/EEC, ” the holder of the authorization (i.e. the licensee) shall be obliged to enable the qualified person to carry out his duties” and according to EU Directive92/25/EEC, Art. 5c), “the applicant for the authorization must undertake to fulfill the obligations incumbent on them under the terms of Article 6”
This clearly shows the legal responsibility of the licensee to enable the QP to carry out his/her duties.

From the above it is clear that:
1. In the first instance the Q.P. should know whether the wholesaler he/she is working for is in possession of a valid trading licence for medicines. Subsequently the Q.P. has the right to full access of that trading licence.
2. The Q.P. should also clearly know which products are being imported and thus for which he/she will be directly held responsible.
3. All correspondence relating to certificates and licensing status of medicinals and general Good Distribution Practice (GDP) should be addressed and/or referred to the Q.P. Therefore in the first instance the wholesale dealer should inform (in writing) all companies abroad as to the new legal requirements set by the DH. Furthermore, this letter shall also bear the name of the appointed Q.P. so that any future documents relating to licensing and regulatory affairs are addressed to the Q.P. In this respect the Q.P. shall be held fully responsible for all the responsibilities listed in DH 174/99 from the date in which the agent informs all companies abroad of the Q.P. requirement (this is so as to avoid bypassing of Q.P.)
4. The licence holder or the managing director shall give the Q.P. the authority to delegate the persons to perform specific tasks e.g. adequate storage conditions during transportation with special regard to those products requiring special handling and storage such as vaccines etc…
5. The licence holder should provide the Q.P. with the necessary resources, human or otherwise, to exercise his role in an effective manner.

Guideline 2
Quality systems/standard operating procedures (SOPs)

1. The Q.P. shall implement and maintain a quality system for the distribution of medicinals imported by the wholesale dealer for whom he/she is responsible.
2. The Q.P. shall devise standard operating procedures (SOPs) for carrying out the tasks related to GDP e.g. stock rotation/control, batch/product recalls, handling of medicinal products such as during transportation.

Guideline 3
Storage Conditions

The Q.P. shall ensure adequate storage conditions of all medicinal products:
a) on the premises: this includes segregation from sanitary facilities, housekeeping, pest control, prevention of contamination from any nearby products, temperature conditions as specified by the manufacturer (i.e. refrigeration, air-conditioning systems). This also includes that suitable precautions are taken in connection with the security of the stores.
b) during delivery: this includes special attention for products requiring special conditions e.g. vaccines.

Guideline 4
Certification/Regulatory Affairs

1. The Q.P. shall ensure that every medicinal product is covered by a valid Certificate of Pharmaceutical Product (CPP) which satisfies the requirements as listed in DH circulars 149/94, 194/95, 22/97, 31/97, 128/98 and 48/99 (and any other future circular relevant to this subject which may be issued by the Department of Health from time to time).
2. The Q.P. should be notified of any incoming shipment of medicinal products so that he/she may ensure that each batch of medicinal product imported is accompanied by the relevant Certificate of Analysis (CoA), unless otherwise indicated by the manufacturer and/or Q.P. for valid Good Manufacturing Practice (GMP)/GDP requirements, which confirms that the specific batch is according to the legal monograph. The Q.P. should also ensure that importers retain such certification for at least five years and one year after the expiry date of the product. Both CPP’s and CoA’s should be made available for inspection on request of the authorities.
3. The Q.P. should submit a new CPP when there are changes to any of the particulars included in the certificate
4. The Q.P. shall inform the MRAU of any changes to the licensing status of the medicinal product imported.
5. The Q.P. should also endorse any kind of correspondence (including submission of new CPPs) sent to the MRAU regarding regulatory affairs.

Guideline 5
Stock control/Pharmacovigilance

1. The Q.P. shall inform the MRAU of any pharmacovigilance issues and take action as necessary e.g. batch/product recall.
2. The Q.P. shall ensure that an adequate turnover of the stored medicinal products takes place.

Guideline 6

1. Ensuring that the right products are delivered to the right and authorised persons within a satisfactory time period. Therefore the DH should send a list of all registered wholesalers and/or distributors and pharmacies with their relevant trading licence number for medicinals to all registered Q.P.s
2. Ensuring that medicine packs, etc. are not opened in order to sell strips, loose tablets, capsules, injections etc. Any breaking of packs or any changes to the packaging or labeling of a medicinal product is considered as a manufacturing activity. Such an activity will need to be licensed by the Health Division and will be subject to the necessary controls to ensure that it is being carried out in accordance with Good Manufacturing Practice (GMP).

Guideline 7
Record keeping

1. Keeping of records of each purchase and sale in an appropriate register/s in a manner that ensures traceability of the origin and destination of products. Such records should be retained by pharmaceutical wholesale dealers for at least five years and should be made available for inspection on request of the authorities. For any transaction in medicinal products received or dispatched, records must at least include the date, name and dosage form of medicinal product, quantity received or supplied, and name and address of supplier/consignee, as appropriate. Records of transactions (excluding deliveries to pharmacies) should also include batch numbers. However the necessary mechanisms/documentation must be in place to nevertheless ensure traceability of these products.
2. Implementing an effective tracking system that enables’ any faulty product to be immediately located.
3. Implementing an effective product recall procedure.

Guideline 8
Compliance to Laws

1. Ensuring that samples of medicines are subject to the same general conditions as for medicinal products intended for sale.
2. Ensuring that the importation and sale of medicinal products which are controlled by the Dangerous Drugs Ordinance and the Drugs (Control) Regulations is covered by a separate license from the Superintendent of Public Health.
3. Ensuring that advertisement of medicinal products by the wholesale dealer for whom he is responsible is made according to the Control of Advertising of Medicinals Regulations, L.N. 85 of 1981. In order to satisfy this requirement the licence holder and/or medical representative/s should in the first instance inform the Q.P. as to any advertising activities they may be thinking of taking up or which they have already taken up.
4. Ensuring compliance, within an adequate notice period, with regulations and circulars pertaining to the wholesale license for medicinal products and GDP, which may be published from time to time.

Guideline 9

The Q.P. should enroll in any specific training courses so as to gain broader knowledge of the ways and means to perform better in the job.

Guideline 10
Reporting Procedures/Handling of Disputes

1. The Q.P. shall have a reporting line to either the licence holder or the managing director.
2. For his part, the licence holder should ensure that there is a written standard operating procedure for receiving advice and comment from the Q.P. and recording subsequent action.
3. Should it prove impossible to resolve a disagreement between the licence holder and the Q.P., the Licensing Authority should be consulted. Whilst a joint referral is clearly to be preferred, either party may approach the Licensing Authority independently. If a Q.P. finds that he/she is in difficulty over his/her statutory responsibilities and the activities being carried out under the licence he/she should, in strict confidence, consult the Licensing Authority.

Guideline 11

The Q.P. shall reserve the right to resign from the post of Q.P. at any point in time due to either:
a) lack of compliance by the wholesale dealer to abide to any instructions given by the Q.P.
b) personal reasons

This should have no detriment on that pharmacist’s employment terms and conditions if he is involved in any other job within that same company

NOTE: These guidelines are not exhaustive. Thus any Q.P. to ensure GDP should implement any procedures he/she deems necessary.

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