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Exemption for substitution of pharmaceuticals
The following preparations have been approved. Exemption must be sought and granted before use of the preparations mentioned below.
Pharmaceutical
|
Substitution |
On-line guide |
| 1 x 10 tablets Buprenorfine 0,2mg |
10 stk. Pentazocine tabs 50 mg |
Pentazocine |
| 10 x 2 ml. Morfin 5 mg/ml |
10 x 1 ml Nubain 10 mg/ml |
Nubain |
| 2 x 15 stk. Triazolam/Hallcion 0,125mg |
100 stk. Haldol 5 mg |
Haldol |
| 1 x 25 tablets Diazepam 5mg |
100 stk. Hydroxyzine 25 mg |
Hydroxyzine |
| 10 x 1 ml. Haloperidol 5mg/ml |
5 x 1 Haldol 5 mg/ml |
Haldol |
| 2 x 1 stk. Chlorhexidine/Ethanol |
Dyna Hex 4 % |
Dyna Hex 4 % |
|
1 x 10 tablets Buprenorfine 0,2mg |
10 stk. Pentazocine tabs 50 mg |
Pentazocine |
|
10 x 2 ml. Morfin 5 mg/ml |
10 x 1 ml Nubain 10 mg/ml |
Nubain |
|
2 x 15 stk. Triazolam/Hallcion 0,125mg |
100 stk. Haldol 5 mg |
Haldol |
|
1 x 25 tablets Diazepam 5mg |
100 stk. Hydroxyzine 25 mg |
Hydroxyzine |
|
10 x 1 ml. Haloperidol 5mg/ml |
5 x 1 Haldol 5 mg/ml |
Haldol |
|
2 x 1 stk. Chlorhexidine/Ethanol |
Dyna Hex 4 % |
Dyna Hex 4 % |
Procedure when seeking exemption for substitution of pharmaceuticals
Exemption may be granted for narcotics that may not be imported to countries outside EU as well as preparations that are not obtainable in countries outside EU or preparations that may not be imported to countries outside EU.
STEP 1
The shipping company contacts the pharmacy to find out which substitution preparations can be delivered. The shipping company then contacts the Centre of Maritime Health Service (CMS) via mail to inform which preparations they would like a substitute of and what the substitution preparations are called.
STEP 2
CMS examines the contents of the substitution preparations and receives a statement from Radio Medical. CMS provides the shipping company with an explanatory statement if the exemption is not granted. If a refusal is the case, the procedure begins again. In case of a positive reply, the shipping company makes sure that directions for use are available in Danish and English.
STEP 3
The shipping company sends an exemption application to the ships as well as directions for use to CMS. CMS then approves these in collaboration with Radio Medical.
CMS issues a”To whom it may concern”, that grants use of substitutions until original medicine can be bought. The shipping company makes sure that the medicine is provided with labels, approved by a pharmacist (e.g. only in English) where after these are forwarded to CMS.
STEP 4
CMS provides Radio Medical with copies of directions for use and labels.
STEP 5
The shipmaster makes sure that directions for use of the substitution preparation is entered in the Control Document under section: Other and new pharmaceuticals.
The shipmaster also ensures that labels for substitution preparations are entered in the Control Document under section: Labels for pharmaceuticals.
Directions concerning these steps are forwarded along with the exemption grant from CMS.
Responsibility
CMS is responsible for issuing and sending directions for use to the shipmaster for entry in the Control Document, and for providing Radio Medical with information.
The shipping company is responsible for finding substitution preparations and drawing up directions for use in Danish and English as well as labels in English as a minimum, approved by a pharmacist.
The shipmaster is responsible for the entry of labels and directions for use in the Control Document.
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